Endoscopic sinus surgery (ESS) to change quality of life for adults with recurrent rhinosinusitis: study protocol for a randomized controlled trial

Abstract Background Endoscopic sinus surgery (ESS) has been used for decades to treat recurrent acute rhinosinusitis episodes (RARS) in adults. RARS results in infectious symptoms, antibiotic courses, sick leaves, and impaired quality of life. Theoretically, the ESS procedure, through improving the drainage of the paranasal sinuses, decreases the symptoms and enhances the quality of life of the RARS patients. Whether this is true has not been reported in a randomized trial yet. Methods We conduct a single-center, non-blinded, randomized, 6-month, parallel group superiority clinical study including 80 adult participants referred to surgical treatment for RARS. The participants will either have ESS or conservative medical treatment (control group). The primary outcome will be the difference between the mean disease-specific Sinonasal Outcome Test 22 (quality of life questionnaire) change scores (from baseline to 6 months) of ESS and control group. Discussion This study will add significant new information to the effect and harms of ESS procedure in the treatment of adults with RARS. Trial registration ClinicalTrials.govNCT04241016. Registered on 17 January 2020

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Efficacy and safety of electro-acupuncture (EA) on insomnia in patients with lung cancer: study protocol of a randomized controlled trial

Trials ◽

10.1186/s13063-020-04721-4 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Hongyu Yue ◽

Shuang Zhou ◽

Huangan Wu ◽

Xuan Yin ◽

Shanshan Li ◽

...

Keyword(s):

Quality Of Life ◽

Lung Cancer ◽

Cancer Survivors ◽

Controlled Trial ◽

Control Group ◽

Life Questionnaire ◽

Efficacy And Safety ◽

Symptom Scale ◽

Significance Level

Abstract Background Cancer-related insomnia (CRI) is one of the most prevalent complaints among cancer survivors and severely impairs patients’ quality of life. As a popular non-pharmacological alternative treatment, acupuncture provides a good clinical curative effect on insomnia. The aim of this trial is to evaluate efficacy and safety of electro-acupuncture on insomnia in patients with lung cancer. Method This is a protocol for a multicenter randomized single-blinded sham-controlled trial. We will randomly assign 252 eligible patients with lung cancer-related insomnia into two groups at a ratio of 1:1, the treatment group (EA) and the control group (sham EA). All treatment will be given 3 times per week for 8 weeks, and a 12-week follow-up will be conducted. The primary outcome will be measured by the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will include sleep parameters recorded from the actigraphy, scores from Quality of Life Questionnaire Core-30 (QLQ-C30), and Patient Health Questionnaire-9 (PHQ-9). All adverse effects during the trial will be assessed by the Treatment Emergent Symptom Scale (TESS). All analyses will be based on ITT principle and performed with the statistical software SPSS (version 24.0) by t test, rank-sum test, chi-square, and so on. A two-sided significance level will be set at 5%. Discussion This large-sample trial protocol will evaluate the efficacy of electro-acupuncture on insomnia in patients with lung cancer. This protocol, if proven to be effective, will contribute to filling the gap in treatment options in the CRI field and provide a promising intervention for insomnia in lung cancer survivors. Trial registration ChiCTR ChiCTR1900026395. Registered on 8 October 2019, http://www.chictr.org.cn/showproj.aspx?proj=44068

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Comparison of the effects of Buteyko and pranayama breathing techniques on quality of life in patients with asthma – a randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215512450521 ◽

2012 ◽

Vol 27 (2) ◽

pp. 133-141 ◽

Cited By ~ 27

Author(s):

Venkatesan Prem ◽

Ramesh Chandra Sahoo ◽

Prabha Adhikari

Keyword(s):

Quality Of Life ◽

Controlled Trial ◽

Control Group ◽

Life Questionnaire ◽

Control Groups ◽

Quality Of Life Questionnaire ◽

Randomized Controlled ◽

Questionnaire Score ◽

And Control

Objective: To compare two breathing exercises (Buteyko and pranayama) with a control group in patients with asthma. Design: Randomized controlled trial. Subjects: One hundred and twenty subjects were randomized to three groups through block randomization. Subjects with an Asthma Quality of Life Questionnaire score <5.5 participated in the study. Setting: Outpatient pulmonary medicine department. Interventions: Subjects in the Buteyko and pranayama groups were trained for 3–5 days and instructed to practise the exercises for 15 minutes twice daily, and for three months duration. The control group underwent routine pharmacological management during the study period. Outcome measures: Asthma Quality of Life Questionnaire, Asthma Control Questionnaire and pulmonary function test. Results: The baseline characteristics were similar in all three groups. Post intervention, the Buteyko group showed better trends of improvement (mean (95% confidence interval), P-value) in total Asthma Quality of Life Questionnaire score than the pranayama (0.47 (–0.008–0.95), P = 0.056) and control groups (0.97 (0.48–1.46), P = 0.0001). In comparison between the pranayama and control groups, pranayama showed significant improvement (0.50 (0.01–0.98), P = 0.042) in total Asthma Quality of Life Questionnaire score. Conclusion: The Buteyko group showed better trends of improvement in quality of life and asthma control than the group performing the pranayama breathing exercise.

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Efficacy of modified Banxia Xiexin decoction in the management of Wei-Pi syndrome (postprandial distress syndrome): study protocol for a randomized, waitlist-controlled trial

Trials ◽

10.1186/s13063-021-05078-y ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Sai Ho Sin ◽

Jing Wu ◽

Yuchen Kang ◽

Kar Hung Kevin Yip ◽

Ngo Suet Kong ◽

...

Keyword(s):

Quality Of Life ◽

Distress Syndrome ◽

Controlled Trial ◽

Control Group ◽

Waitlist Control ◽

Link Type ◽

Waitlist Control Group ◽

Banxia Xiexin Decoction

Abstract Background Postprandial distress syndrome manifests as a feeling of fullness and early satiation that can significantly reduce the quality of life of the patients. In Chinese medicine (CM), the syndrome is traditionally regarded as the Wei-Pi syndrome, and Banxia Xiexin decoction (BXD) has been used in the empirical treatment of the same for a long time. The current study aims to evaluate the efficacy of modified BXD in the management of Wei-Pi syndrome. Methods/design A randomized, waitlist-controlled trial will be conducted. A total of 84 patients with Wei-Pi syndrome will be randomized into the BXD or waitlist control group in a ratio of 1:1. The patients in the BXD group will receive the semi-individualized BXD on the basis of the syndrome differentiation in CM, for a duration of 3 weeks and will be under follow-up for further 3 weeks after the completion of therapy. Conversely, the patients in the waitlist control group will undergo the same intervention and follow-up after a 3-week waiting period. In the current study, the primary outcome will be the variation in the scores pertaining to the global scale of the Quality of Life Questionnaire for Functional Digestive Disorders after 3 weeks. The secondary outcomes include the variations in the scores pertaining to the Hospital Anxiety and Depression Scale and the EuroQoL 5-dimension 5-level Questionnaire and the results of the liver and kidney function tests. Discussion This trial will assess the efficacy of modified BXD in improving the clinical symptoms and quality of life of the patients suffering from Wei-Pi syndrome. Trial registration ClinicalTrials.govNCT04398888. Registered on May 21, 2020

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Adding a smartphone app to global postural re-education to improve neck pain, posture, quality of life, and endurance in people with nonspecific neck pain: a randomized controlled trial

Trials ◽

10.1186/s13063-021-05214-8 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Fatemeh Abadiyan ◽

Malihe Hadadnezhad ◽

Zohre Khosrokiani ◽

Amir Letafatkar ◽

Haniyeh Akhshik

Keyword(s):

Quality Of Life ◽

Neck Pain ◽

Controlled Trial ◽

Neck Disability Index ◽

Chronic Neck Pain ◽

Analysis Of Covariance ◽

Smartphone App ◽

Control Group ◽

Life Questionnaire

Abstract Background In this study, the effect of adding a smartphone app to an 8-week global postural reeducation (GPR) on neck pain, endurance, quality of life, and forward head posture (FHP) in patients with chronic neck pain and FHP was evaluated. Methods Sixty male and female office workers (38.5 ± 9.1 years) with chronic neck pain were randomly assigned into three groups: group 1 (GPR+ a smartphone app, n = 20), group 2 (GPR alone, n = 20), and group 3 (the control group, n = 20). The primary outcome was pain and the secondary outcomes were disability, quality of life, endurance, and posture. Pain, disability, endurance, quality of life, and posture were evaluated using the visual analog scale (VAS), neck disability index (NDI), progressive iso-inertial lifting evaluation (PILE) test, quality of life questionnaire (SF-36), and photogrammetry, respectively, at pre-and post-8-week interventions. A one-way analysis of covariance (ANCOVA) has been conducted to statistically analyze the data. Results The GPR+ a smartphone app had statistically significant improvements versus GPR alone in pain (mean difference, − 2.05 ± 0.65, ES (95% CI) − 0.50 (− 1.04 to − 0.01), P = 0.04), disability (difference = 11.5 ± 1.2, ES (95% CI) = 0.31 (0.22 to 0.97), p = 0.033), FHP (difference = 1.6 ± 0.2, ES (95% CI) = 0.31 (0.09 to 0.92), p = 0.047), and endurance (difference = 2 ± 3.3, ES (95% CI) = 0.51 (0.02 to 1.03), p = 0.039). Both of the GPR+ a smartphone app and GPR alone groups had statistically significant differences versus the control group in all outcomes. Conclusion When a workplace assessment and management could not be as part of any intervention, adding a smartphone app to GPR for NP may be an appropriate tool to administer a home and work exercise program resulting in elevating pain and disability, as well as improving FHP and endurance. Trial registration Current Controlled Trials using the UMIN-RCT website UMIN000039720. Retrospectively registered on January 9, 2020.

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Counseling in Primary Care Improves Depression and Quality of Life

Clinical Practice and Epidemiology in Mental Health ◽

10.2174/1745017901208010152 ◽

2012 ◽

Vol 8 (1) ◽

pp. 152-157 ◽

Cited By ~ 5

Author(s):

MG Carta ◽

D Petretto ◽

S Adamo ◽

KM Bhat ◽

ME Lecca ◽

...

Keyword(s):

Quality Of Life ◽

Controlled Trial ◽

World Health ◽

Control Group ◽

Life Questionnaire ◽

Experimental Sample ◽

World Health Organization Quality ◽

Treatment As Usual ◽

Experimental Group

Introduction:To measure the effectiveness on Quality of Life of adjunctive cognitive behavioral counseling in the setting of General Practitioners (GPs) along with the treatment as usual (TAU;) for the treatment of depression.Methods:Six month-controlled trial of patients who were referred to randomly assigned GPs (four for experimental group of patients and ten for the control) was done. Experimental sample had 34 patients with DSM-IV diagnosis of Depression (Depressed Episode, Dysthymia, or Adjustment Disorder with Depressed Mood) receiving the TAU supplemented with counseling. Control group had 30 patients with diagnosis of Depression receiving only the TAU.Results:The Beck Depression Inventory (BDI) score improved in both groups. Patients in the experimental group showed greater improvement compared to the control group at T2. The World Health Organization Quality OF Life Questionnaire (WHOQOL) score also improved in the experimental group but not in the control group. The improvement in the experimental group was statistically significant in terms of both BDI and WHOQOL scores.Conclusions:Adding counseling to TAU in general medical practice settings is more effective in controlling the symptoms of depression and improving the quality of life as measured over a period of six months, than TAU alone. These results while encouraging, also calls for a larger study involving a largersample size and a longer period of time.

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Effects of a Few Minutes of Abdominal Drawing-in Maneuver on Balance Test Results

10.32592/ircmj.2021.23.5.774 ◽

2021 ◽

Keyword(s):

Quality Of Life ◽

Repeated Measures ◽

Controlled Trial ◽

Intervention Group ◽

Educational Interventions ◽

Control Group ◽

Life Questionnaire ◽

Menopausal Women ◽

Significant Difference

Background: Menopause is a natural part of women's lives and is associated with a series of complications that can impair their quality of life. This study was conducted to determine the effect of educational interventions based on the Multi-Theory Model (MTM) on the quality of life among menopausal women. Methods: This randomized controlled trial was conducted on 80 menopausal women who met the inclusion criteria and were selected through the multi-stage stratified random sampling method. The participants were randomly allocated to either the control or intervention group (40 subjects per group). The intervention group participated in five 45-min educational sessions based on the MTM on the predetermined days of the week. The quality of life level scores were collected at baseline, immediately, and three months after the intervention using the Menopause-Specific Quality of Life questionnaire (MENQOL). On the other hand, the control group did not receive any intervention during the study period. Results: Analysis of variance of repeated measures showed a significant interaction between time and intervention. Therefore, the independent t-test was used to compare the mean score of quality of life, before, immediately, and three months after the intervention. The results showed a significant difference between the two groups regarding the scores immediately after and three months after the intervention. Conclusion: Structured educational program based on the MTM could be used as a simple and noninvasive intervention that helps menopausal women’s general health through menopausal symptoms relief, thereby improving their quality of life. Further interventions with larger sample sizes may be required to confirm these findings.

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Platelet Gel for Endoscopic Sinus Surgery

Annals of Otology Rhinology & Laryngology ◽

10.1177/000348940511400908 ◽

2005 ◽

Vol 114 (9) ◽

pp. 699-704 ◽

Cited By ~ 31

Author(s):

Jonathan Pomerantz ◽

Jay M. Dutton

Keyword(s):

Quality Of Life ◽

Growth Factors ◽

Endoscopic Sinus Surgery ◽

Healing Process ◽

Small Population ◽

Packing Material ◽

Sinus Surgery ◽

Control Group ◽

Platelet Gel

Objectives: New techniques are being utilized to improve outcomes for endoscopic sinus surgery, including newer forms of packing. Platelet gel is an innovative technique that holds many advantages, including comfort, hemostasis, and growth factors that may improve wound healing. This report discusses the theoretical advantages of this packing material and describes the initial results in a cohort of patients who underwent endoscopic sinus surgery. Methods: A cohort of patients who underwent endoscopic sinus surgery were interviewed and evaluated after the placement of platelet gel. A quality of life study was also administered for further understanding. Results: None of the patients in the study had postoperative epistaxis that required additional packing, and there were no instances of synechia formation or exuberant granulation tissue. Although not statistically significant because of a small population, the quality of life scores did show improvement over the control group. Conclusions: Platelet gel used as a packing material after endoscopic sinus surgery offers efficient hemostatic properties, as well as growth factors that can advance the healing process. The quality of life of the patient may be improved by the use of platelet gel packing.

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Total or partial tonsillar resection (tonsillectomy or tonsillotomy) to change the quality of life for adults with recurrent or chronic tonsillitis: study protocol for a randomised controlled trial

Trials ◽

10.1186/s13063-021-05539-4 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Aleksi Laajala ◽

Paulus Tokola ◽

Timo J. Autio ◽

Timo Koskenkorva ◽

Mikko Tastula ◽

...

Keyword(s):

Quality Of Life ◽

Controlled Trial ◽

Randomised Trial ◽

Chronic Tonsillitis ◽

Recurrent Tonsillitis ◽

New Information ◽

Parallel Group ◽

The Difference ◽

Randomised Controlled

Abstract Background Tonsillar surgery has been used for decades to treat recurrent and chronic tonsillitis in adults. Recurrent and chronic tonsillitis result in disturbing symptoms, treatment costs, sick leave, and impaired quality of life (QoL). Theoretically, removing all or part of the altered pathological palatal lymphoid tissue alleviates the symptoms and enhances the QoL. Whether this is true with total or partial tonsillar resection (tonsillectomy (TE) and tonsillotomy (TT), respectively) has not been reported in a randomised trial yet. Methods We conduct a multicentre, partly blinded, randomised, 6-month, parallel-group clinical study including 285 adult participants referred to surgical treatment for chronic or recurrent tonsillitis. The participants will either have TE, TT or watchful waiting (WW). The primary outcome will be the difference between the mean disease-specific Tonsillectomy Outcome Inventory-14 (QoL questionnaire) scores at 6 months. Comparison is made firstly between the combined TE+TT and WW groups (superiority analysis), and secondly between the TE and TT groups (non-inferiority analysis). Discussion This study will add significant new information to the effects and harms of TE and TT procedures in the treatment of adults with chronic or recurrent tonsillitis. Trial registration ClinicalTrials.gov: NCT04657549

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Efficacy and Safety of Electro-Acupuncture (EA) on Insomnia in Patients with Lung Cancer: Study Protocol of a Randomized Controlled Trial

10.21203/rs.3.rs-20546/v1 ◽

2020 ◽

Author(s):

Hongyu Yue ◽

Shuang Zhou ◽

Huangan Wu ◽

Xuan Yin ◽

Shanshan Li ◽

...

Keyword(s):

Quality Of Life ◽

Lung Cancer ◽

Cancer Survivors ◽

Primary Outcome ◽

Controlled Trial ◽

Control Group ◽

Life Questionnaire ◽

Efficacy And Safety ◽

Secondary Outcomes

Abstract Background : Cancer-related insomnia (CRI) is one of the most prevalent complaints among cancer survivors and severely impairs patients’ quality of life. As a popular non-pharmacological alternative treatment, acupuncture provides a good clinical curative effect on insomnia. The aim of this trial is to evaluate efficacy and safety of electro-acupuncture on insomnia in patients with lung cancer. Method : This is a protocol for a multicenter randomized single-blinded sham-controlled trial. We will randomly assign 252 eligible patients with lung cancer-related insomnia into two groups at a ratio of 1:1, the treatment group (EA) and the control group (sham EA). All treatment will be given 3 times per week for 8 weeks, and a 12-week follow-up will be conducted. The primary outcome will be measured by the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will include sleep parameters recorded from the actigraphy, scores from Quality of Life Questionnaire Core-30 (QLQ-C30), and Patient Health Questionnaire-9 (PHQ-9). All adverse effects during the trial will be assessed by the Treatment Emergent Symptom Scale (TESS). The primary outcome will be assessed at baseline, week 4, week 8, week 12 and week 20. The secondary outcomes will only be assessed at baseline and week 8. Discussion : This large-sample trial protocol will evaluate the efficacy of electro-acupuncture on insomnia in patients with lung cancer. This protocol, if proven to be effective, will contribute to filling the gap in treatment options in the CRI field and provide a promising intervention for insomnia in lung cancer survivors. Trial registration: ChiCTR, ChiCTR1900026395, Registered 8 October 2019, http://www.chictr.org.cn/showproj.aspx?proj=44068

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Efficacy and Safety of Electro-Acupuncture (EA) on Insomnia in Patients with Lung Cancer: Study Protocol of a Randomized Controlled Trial

10.21203/rs.3.rs-20546/v2 ◽

2020 ◽

Author(s):

Hongyu Yue ◽

Shuang Zhou ◽

Huangan Wu ◽

Xuan Yin ◽

Shanshan Li ◽

...

Keyword(s):

Quality Of Life ◽

Lung Cancer ◽

Cancer Survivors ◽

Controlled Trial ◽

Control Group ◽

Life Questionnaire ◽

Efficacy And Safety ◽

Symptom Scale ◽

Significance Level

Abstract Background: Cancer-related insomnia (CRI) is one of the most prevalent complaints among cancer survivors and severely impairs patients’ quality of life. As a popular non-pharmacological alternative treatment, acupuncture provides a good clinical curative effect on insomnia. The aim of this trial is to evaluate efficacy and safety of electro-acupuncture on insomnia in patients with lung cancer. Method: This is a protocol for a multicenter randomized single-blinded sham-controlled trial. We will randomly assign 252 eligible patients with lung cancer-related insomnia into two groups at a ratio of 1:1, the treatment group (EA) and the control group (sham EA). All treatment will be given 3 times per week for 8 weeks, and a 12-week follow-up will be conducted. The primary outcome will be measured by the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will include sleep parameters recorded from the actigraphy, scores from Quality of Life Questionnaire Core-30 (QLQ-C30), and Patient Health Questionnaire-9 (PHQ-9). All adverse effects during the trial will be assessed by the Treatment Emergent Symptom Scale (TESS). All analyses will be based on ITT principle and performed with the statistical software SPSS (version 24.0) by t test, rank-sum test, chi-square and so on. A two-sided significance level will be set at 5%.Discussion: This large-sample trial protocol will evaluate the efficacy of electro-acupuncture on insomnia in patients with lung cancer. This protocol, if proven to be effective, will contribute to filling the gap in treatment options in the CRI field and provide a promising intervention for insomnia in lung cancer survivors. Trial registration: ChiCTR, ChiCTR1900026395, Registered 8 October 2019, http://www.chictr.org.cn/showproj.aspx?proj=44068

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