The effects of an olive-oil massage on hemodialysis patients suffering from fatigue at a hemodialysis unit in southern India – a randomized controlled trial

Abstract Objectives To determine the effects that an olive oil massage has on fatigue among patients undergoing hemodialysis, and the associated sociodemographic factors that can reduce fatigue. Methods The study used true experimental pre- and post-test research design. A total of 200 patients were recruited in a selected hemodialysis unit in southern India and were allocated to either a study or control group by randomization, with 100 patients in each group. All the patients in the intervention group were given a lower back and lower leg massage using olive oil at the beginning, and after every hour, of their hemodialysis using olive oil for a period of eight weeks. In contrast, the control group continues to receive routine care. The level of fatigue was measured using the Fatigue Severity Scale both before and after massage therapy. Results Between 73 and 80% of patients were suffering from severe fatigue and the mean fatigue score was 5.53 (SD 1.82) and 5.56 (SD 1.57) for the study and control group, respectively. After eight weeks of massage therapy, the results showed that 53% of patients in the study group showed borderline fatigue, with a mean score of 4.39 (SD 2.37), whereas in the control group 73% patients showed severe fatigue, with a mean score of 5.17 (SD 2.00). The independent t-test between the study and the control group showed a statistically significant reduction in fatigue in the study group with a mean difference (MD) of 3.56 (t=−1.24; p=0.000). There were also statistically significant changes noted in gender and in the duration of the hemodialysis (χ 2 = 6.043; p=0.049) and (χ 2 = 6.611; p=0.046) respectively. Conclusion The study concluded that patients undergoing hemodialysis experienced moderate to severe levels of fatigue. In patients with no or mild anemia, massage has been shown to decrease fatigue and increase energy levels among patients undergoing hemodialysis for chronic kidney disease.

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Application Of Predialytic Exercise To Reduce Fatigue In-Patient Undergoing Hemodialysis

South East Asia Nursing Research ◽

10.26714/seanr.3.1.2021.28-32 ◽

2021 ◽

Vol 3 (1) ◽

pp. 28

Author(s):

Nugroho Lazuardi

Keyword(s):

Chronic Kidney Disease ◽

Kidney Disease ◽

Exercise Intervention ◽

Intervention Group ◽

Control Group ◽

Electrolyte Balance ◽

Fatigue Score ◽

Severe Fatigue ◽

Moderate Fatigue ◽

Quasi Experimental

Chronic kidney disease is an irreversible and slow-progressing disorder of kidney function so that the kidneys are unable to maintain the body's metabolism, fluid and electrolyte balance and cause uremia which requires dialysis or kidney transplantation. Hemodialysis is management to treat chronic kidney disease that is carried out for life so that the complications that often arise are fatigue, cramps, anxiety, pain. The phenomenon found in the Hemodialysis Room of the Tugurejo Hospital Semarang, there were 34% of the 84 patients who experienced fatigue which was characterized by lethargy, weakness, drowsiness, dizziness. This research is a quantitative study with a quasi-experimental design. The sample size is 4 respondents in the intervention group without a control group. Measurement of the level of fatigue (pre and post-test) using the PFS (Piper Fatigue Scale) which contains 22 subjective statements. Predialytic Exercise intervention is given for 5 sessions with a duration of 10-15 minutes. The results of this study indicate that the fatigue level of hemodialysis patients has decreased after the intervention of predialytic exercise for 5 sessions. The fatigue score of respondents 1 has decreased from a score of 4.8 (moderate fatigue) to 3.2 (mild fatigue), respondent 2 from a score of 6.3 (moderate fatigue) to 4.3 (moderate fatigue), respondent 3 from score 9 (severe fatigue) to 7 (severe fatigue), and respondent 1 from a score of 4.9 (moderate fatigue) to 2.4 (mild fatigue). The results of this study indicate that there is a decrease in each dimension of fatigue levels so that predialytic exercise intervention is effective to reduce fatigue in patients undergoing hemodialysis.

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Impact of supplementation with "multivitamin-mineral" specially formulated to improve fatigue and inflammatory state in patients with multiple sclerosis: A triple-blind, randomized, placebo-controlled trial

Current Journal of Neurology ◽

10.18502/cjn.v19i4.5545 ◽

2021 ◽

Author(s):

Sama Bitarafan ◽

Elmira Karimi ◽

Abdorreza Naser Moghadasi ◽

Razieh Sadat K Kazemi-Mozdabadi ◽

Zinat Mohammadpour ◽

...

Keyword(s):

Multiple Sclerosis ◽

Controlled Trial ◽

Intervention Group ◽

Complementary Therapy ◽

Interleukin 4 ◽

Control Group ◽

Fatigue Score ◽

Number Of Patients ◽

Significant Difference ◽

Inflammatory State

Background: Multiple sclerosis (MS) is an inflammatory disease of the central nervous system (CNS) with the most common complaint of fatigue. A high number of patients with MS are interested in taking dietary supplements as a complementary therapy. We propose a specially formulated supplement for patients with MS and aim to evaluate its effects on fatigue. Methods: This study was a triple-blind, randomized, placebo-controlled trial using a stratified randomization method according to sex. 46 eligible patients participated in the study, 23 in the placebo group and 23 in the intervention group. The intervention group received two capsules of multivitamin-mineral (MVM) daily for 3 months. Measurements of fatigue and cytokines were performed in all patients at the baseline and after the 3-month intervention Results: Finally, information of 41 participants was used for data analysis. However, fatigue was decreased after supplementation than before, in the intervention group (P = 0.005). There was no significant difference (P = 0.090) between the change of fatigue score in the MVM group (-3.00 ± 4.42) and the control group (-0.40 ± 5.14). Among cytokines, Interleukin 4 (IL-4) significantly increased in the intervention group compared to the placebo (P = 0.030). Conclusion: Our study showed that the present MVM probably could improve the inflammatory state and fatigue in patients with MS.

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The Effect of Foot Reflexology on Amnesia in Patients Undergoing Electroconvulsive Therapy: A Randomized Clinical Trial

Journal of Caring Sciences ◽

10.34172/jcs.2021.004 ◽

2021 ◽

Vol 10 (1) ◽

pp. 15-21

Author(s):

Hossein Namdar Areshtanab ◽

Saeed Alinejad Machiani ◽

Hossein Ebrahimi ◽

Parvin Sarbakhsh ◽

Sakineh Goljarian ◽

...

Keyword(s):

Olive Oil ◽

Repeated Measures ◽

Controlled Trial ◽

Intervention Group ◽

Invasive Technique ◽

Control Group ◽

Non Invasive ◽

Chi Squared ◽

Spss Software ◽

And Control

Abstract Introduction:Electroconvulsive therapy (ECT) is the oldest procedure among the early biological treatments introduced in psychiatry. However, the most debated and treatment-limiting adverse effect of ECT is amnesia. Therefore, due to the restriction of the use of drugs to manage amnesia in patients undergoing ECT, the present study investigated the effect of reflexology on amnesia. Methods:In this randomized controlled trial, 68 patients who met the inclusion criteria were randomly allocated to intervention and control groups. The intervention group received foot reflexology with olive oil 20 minutes a day for 3 days, while the control group was given a gentle foot rub with olive oil 20 minutes a day for 3 days. The amnesia rate of all patients was measured by the Galveston Orientation and Amnesia Test (GOAT) 30 minutes after the end of ECT. The data were analyzed using SPSS software version 11.5 and t-test, chi-squared test, and repeated measures ANOVA. Results:The results showed that reflexology significantly increased recalling scores in the intervention group compared to the control group. Foot reflexology seems to be effective in managing amnesia in patients after ECT. Conclusion:Foot reflexology, as a relatively simple, inexpensive, and non-invasive technique with few side effects, can be used to manage amnesia in patients after ECT.

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Effects of Qigong Exercise on Fatigue, Anxiety, and Depressive Symptoms of Patients with Chronic Fatigue Syndrome-Like Illness: A Randomized Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2013/485341 ◽

2013 ◽

Vol 2013 ◽

pp. 1-8 ◽

Cited By ~ 19

Author(s):

Jessie S. M. Chan ◽

Rainbow T. H. Ho ◽

Chong-wen Wang ◽

Lai Ping Yuen ◽

Jonathan S. T. Sham ◽

...

Keyword(s):

Depressive Symptoms ◽

Chronic Fatigue Syndrome ◽

Controlled Trial ◽

Alternative Therapy ◽

Intervention Group ◽

Chronic Fatigue ◽

Control Group ◽

Complementary And Alternative Therapy ◽

Fatigue Score ◽

Fatigue Syndrome

Background. Anxiety/depressive symptoms are common in patients with chronic fatigue syndrome- (CFS-) like illness. Qigong as a modality of complementary and alternative therapy has been increasingly applied by patients with chronic illnesses, but little is known about the effect of Qigong on anxiety/depressive symptoms of the patients with CFS-like illness.Purpose. To investigate the effects of Qigong on fatigue, anxiety, and depressive symptoms in patients with CFS-illness.Methods. One hundred and thirty-seven participants who met the diagnostic criteria for CFS-like illness were randomly assigned to either an intervention group or a waitlist control group. Participants in the intervention group received 10 sessions of Qigong training twice a week for 5 consecutive weeks, followed by home-based practice for 12 weeks. Fatigue, anxiety, and depressive symptoms were assessed at baseline and postintervention.Results. Total fatigue score [F1,135=13.888,P<0.001], physical fatigue score [F1,135=20.852,P<0.001] and depression score [F1,135=9.918,P=0.002] were significantly improved and mental fatigue score [F1,135=3.902,P=0.050] was marginally significantly improved in the Qigong group compared to controls. The anxiety score was not significantly improved in the Qigong group.Conclusion. Qigong may not only reduce the fatigue symptoms, but also has antidepressive effect for patients with CFS-like illness. Trial registrationHKCTR-1200.

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Do Clinical Librarians Matter? The First Randomized Controlled Trial in Librarianship

Evidence Based Library and Information Practice ◽

10.18438/b8rg8f ◽

2007 ◽

Vol 2 (4) ◽

pp. 84 ◽

Cited By ~ 2

Author(s):

Jonathan Eldredge

Keyword(s):

Randomized Controlled Trial ◽

Information Seeking ◽

Controlled Trial ◽

Healthcare Providers ◽

Intervention Group ◽

Control Group ◽

Study Group ◽

Reference Services ◽

Randomized Controlled ◽

Information Requests

A review of: Marshall, Joanne Gard, and Victor R. Neufeld. “A Randomized Controlled Trial of Librarian Educational Participation in Clinical Settings.” Journal of Medical Education 56.5 (1981): 409-16. Objectives – To determine whether clinical librarian services cause healthcare providers to change their information seeking behaviors. To evaluate librarians’ educational roles for clinicians, patients, and patients’ families. Design – Randomized controlled trial. Setting – An academic, health-sciences-center, teaching hospital in Canada. Subjects – A total of eight teams, each consisting of at least eight members who represented at least three different types of health professionals. Four teams (rheumatology, obstetrics, neurology, and pediatrics) were randomized into the intervention group to receive clinical librarian services for a six-month period, and four teams (hematology, diabetic day care, pain clinic, and community psychiatry) were randomized into the control group that did not receive clinical librarian services. Methods – Two half-time clinical librarians attended the intervention groups’ rounds, clinics, and conferences identified as having educational components or where questions would likely arise related to patient care. The two clinical librarians handled 600 perceived or actual information requests, delivered 1,200 documents, and provided over 3,000 references during the twelve-month study period of September 1978 to August 1979. The typical service consisted of the clinical librarian securing one or two articles relevant to the question raised along with pertinent references placed in a “hot topics” ring binder located in the clinical wards. Healthcare providers were alerted to or reminded about the clinical librarian service through a brochure and an exhibit. The brochure also advertised the clinical librarian service to patients or their families. Approximately 24% of all information requests fielded by the clinical librarians originated from patients or their families. The remaining information requests originated from physicians (40%), allied health professionals (21%), and nurses (15%) belonging to these interdisciplinary intervention group teams. Main Results – Trained impartial interviewers conducted in-depth interviews with members of both the intervention group teams and the control group teams immediately following the first six-month study period and then again three months after the end of the study period. Following the initial six months of the study period, 67% of the members of the intervention group compared to 37% of the members of the study group used the library’s reference services. Three months after the study period had ended, 76% of the members of the intervention group compared to 49% of the members of the study group had used the reference services. The authors reported in a one-sentence page note that these findings were statistically significant beyond the .05 level as measured by chi-square and analysis of variance tests. Three months after the study period had ended, 60% of the members of the intervention group compared to 38% of the members of the study group reported rating highly the use of library resources. In addition, three months after the study period had ended, 36% of the members of the intervention group compared to 27% of the members of the study group reported rating highly the use of reference librarians. Although patients or their families were generally positive in rating the clinical librarians’ services, they proved to be a difficult population upon which to conduct a comprehensive follow-up evaluation study once patients had left the hospital. Conclusion – The authors conclude that the clinical librarian services to the four intervention groups had changed the group members’ information seeking behavior.

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Promoting the Community's Ability to Detect and Respond to Suicide Risk Through an Online Bystander Intervention Model-Informed Tool

Crisis ◽

10.1027/0227-5910/a000708 ◽

2020 ◽

pp. 1-7

Author(s):

Karien Hill ◽

Shawn Somerset ◽

Ralf Schwarzer ◽

Carina Chan

Keyword(s):

Suicide Prevention ◽

Suicide Risk ◽

Controlled Trial ◽

Intervention Group ◽

Bystander Intervention ◽

Self Report ◽

Innovative Technology ◽

Control Group ◽

Intervention Model ◽

Standard Material

Abstract. Background: The public health sector has advocated for more innovative, technology-based, suicide prevention education for the community, to improve their ability to detect and respond to suicide risk. Emerging evidence suggests addressing the bystander effect through the Bystander Intervention Model (BIM) in education material may have potential for suicide prevention. Aims: The current study aimed to assess whether BIM-informed tools can lead to improved readiness, confidence and intent in the community to detect and respond to suicide risk in others. Method: A sample of 281 adults recruited from the community participated in a randomized controlled trial comprising a factsheet designed according to the BIM (intervention group) and a standard factsheet about suicide and mental health (control group). Participants' self-reported detecting and responding to suicide risk readiness, confidence, and intent when presented with a suicidal peer was tested pre- and postintervention and compared across time and between groups. Results: The intervention group had significantly higher levels of detecting and responding to suicide risk readiness, confidence, and intent than the control group at postintervention (all p < .001) with moderate-to-large effect sizes. Limitations: The study was limited by a homogenous sample, too low numbers at follow-up to report, and self-report data only. Conclusion: This study demonstrates BIM-informed suicide prevention training may enhance the community's intervention readiness, confidence, and intent better than current standard material. Further testing in this area is recommended. While results were statistically significant, clinical significance requires further exploration.

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Breastfeeding Training through Role-Play and Effects on Mother-infant Attachment Behaviours: A Randomised Controlled Trial

Africa Journal of Nursing and Midwifery ◽

10.25159/2520-5293/6232 ◽

2020 ◽

Vol 22 (1) ◽

Author(s):

Farokh Saljughi ◽

Mitra Savabi-Esfahani ◽

Shahnaz Kohan ◽

Soheila Ehsanpour

Keyword(s):

Pregnant Women ◽

Maternal Employment ◽

Controlled Trial ◽

Role Play ◽

Intervention Group ◽

Control Group ◽

Maternal Behaviour ◽

Infant Attachment ◽

Significant Difference ◽

History Of

Mother-infant attachment is an intimate, lasting and satisfying relationship that leads to better cognitive, emotional and social growth of the infant. The aim of this study was to determine the effects of breastfeeding training by role-play on mother-infant attachment behaviours. This research was a randomised clinical trial (parallel design). Inclusion criteria were: no history of mental disorders; ability to read and write the Persian language to complete the questionnaire; no history of drug and tobacco intake in primigravida women. The sample comprised 100 pregnant women (in 2 groups), selected through simple random sampling at healthcare centres. The researcher reviewed prenatal care registries of selected healthcare centres and extracted the names of pregnant women in their early third trimester. The data were imported into randomisation software. The control group received routine breastfeeding training, while the intervention group received routine training together with training through role-play. The data collection tool was the Maternal Behaviour Inventory Questionnaire. Consequently 75 samples were analysed in SPSS16. Independent t-tests and chi-square tests were used to examine the difference between the two groups. Results showed that the mean score of mother-infant attachment one week after delivery was significantly higher in the intervention group in comparison to that in the control group (p<0.001). No significant difference was observed between the two groups in maternal age, age of marriage, neonatal gender, maternal employment and education, number of parity, and number of abortions (P>0.05). Since breastfeeding training through role-play could affect mother-infant attachment, it is suggested that this type of training should be provided for pregnant women to promote mother-infant attachment and exclusive breastfeeding.

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The Effect of Reflexology on Labor Pain and Length Among Primiparous Women: A Randomized Controlled Trial

International Electronic Journal of Medicine ◽

10.31661/iejm805 ◽

2018 ◽

Vol 7 ◽

Author(s):

Azita Kamjoo

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Active Phase ◽

Labor Pain ◽

Control Group ◽

Singleton Pregnancy ◽

Group Data ◽

Significant Difference ◽

Labor Length ◽

Primiparous Women

Background: Pain control is considered as the key issue in modern midwifery. Along with medical painkillers, reflexology is viewed as a non-medical and noninvasive method. Hence, we aimed to investigate the effect of reflexology on the intensity of pain and length of labor. Materials and Methods: In this clinical trial, participants included 240 Iranian primiparous women with term and singleton pregnancy. Having a 3-4 cm cervical dilatation once they visited the hospital. Through a convenient sampling method, they were selected and then randomly divided into two groups. In the intervention group, reflexology was performed, and the intensity of pain during the active phase of labor along with the length of labor in the active phase was measured by visual analog scale (VAS) and compared with the control group. Data were analyzed using descriptive statistics, t-test, and Mann-Whitney U-test. Result: Data analysis showed a statistically significant difference between the intensity of pain in the 5-7 and 8-10 cm dilatation in the two groups (P=0.01). Moreover, the labor length in the active phase was found to be significantly shorter in the intervention group (P<0.001). Conclusion: It appears that reflexology can lead to a reduction in the pain and length of labor. Therefore, through instructing this technique, a goal of midwifery, which is reducing labor pain and its length can be achieved. Keywords: Reflexology, Labor Pain, Labor Length, Primiparous Women

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Effectiveness of an Educational Intervention in Reducing New International Postgraduates’ Acculturative Stress in Malaysian Public Universities: Protocol for a Cluster Randomized Controlled Trial (Preprint)

10.2196/preprints.12950 ◽

2018 ◽

Author(s):

Musheer Abdulwahid Al-Jaberi ◽

Muhamad Hanafiah Juni ◽

Hayati Kadir Shahar ◽

Siti Irma Fadhilah Ismail ◽

Murad Abdu Saeed ◽

...

Keyword(s):

International Students ◽

Acculturative Stress ◽

Educational Program ◽

Public Universities ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Policy Makers ◽

Randomized Controlled ◽

Cluster Randomized

BACKGROUND Universities around the world, including Malaysia, have attracted many international students from different countries. Research has reported that acculturative stress resulting from international students’ attempts to adjust to the cultures of host countries is one of the most challenging issues that affects their lives in general and academic lives in particular. OBJECTIVE This study aims to examine the effectiveness of an educational intervention on acculturative stress among new postgraduate international students joining Malaysian public universities. METHODS A cluster randomized controlled trial design with Malaysian public universities as the unit of randomization will be used in this study. Public universities will be randomized in a 1:1 ratio to be either in the intervention (educational program) or control group (waiting list). Participants in the intervention group will receive 7 sessions in 9 hours delivered by an expert in psychology and the researcher. The control group will receive the intervention once the 3-month follow-up evaluation is completed. RESULTS The data will be analyzed using the generalized estimation equation with a confidence interval value of 95%; significant differences between and within groups are determined as <i>P</i><.05. The results of the study underlie the effectiveness of educational program in decreasing acculturative stress of new international students and enabling them to cope with a new environment. The results of this study will contribute to previous knowledge of acculturative stress, acculturation, and adjustment of international students. Furthermore, such results are expected to play a role in raising university policy makers’ awareness of their postgraduate international students’ acculturative stress issues and how they can help them avoid such stress and perform well in their academic life. CONCLUSIONS We expect that the intervention group will score significantly lower than the wait-list group on the immediate and 3-month postintervention evaluation of acculturative stress and achieve a higher level of adjustment. Results will have implications for international students, policy makers at universities, the Malaysian Ministry of Higher Education, and future research. CLINICALTRIAL Clinical Trials Registry India CTRI/2018/01/011223; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1= 21978&amp;EncHid=&amp;userName=Muhamad%20Hanafiah%20Juni INTERNATIONAL REGISTERED REPORT PRR1-10.2196/12950

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Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

10.2196/preprints.16141 ◽

2019 ◽

Author(s):

Jan van Lieshout ◽

Joyca Lacroix ◽

Aart van Halteren ◽

Martina Teichert

Keyword(s):

Randomized Controlled Trial ◽

Medication Adherence ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Community Pharmacies ◽

Web Based ◽

Randomized Controlled ◽

Tailored Interventions ◽

Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

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