The feasibility of a novel injectable hydrogel for protecting artificial gastrointestinal ulcers after endoscopic resection: an animal pilot study

AbstractRecently, covering materials for protecting post-endoscopic ulcers are being developed using hydrogels. Existing hydrogels are not ideal coating materials because it is difficult to control their physical properties. Therefore, we conducted an animal pilot study to investigate the protective effect of a novel ulcer coating material, whose physical properties can be easily controlled and designed. We applied the novel injectable hydrogel to artificial ulcers induced on the gastric mucosa of rats. Rats were assigned to the hydrogel or the control group. To measure the protective effect of hydrogel on ulcers, the perforation rate, ulcer diameter, and ulcer area were evaluated 48 h after gel application. As secondary endpoints, we assessed the residual rate of the hydrogel at the bottom of the ulcer, performed histological analysis, and analyzed adverse events associated with hydrogel. The perforation rate was significantly lower (16% vs. 75%) and the mean diameter of ulcers was significantly smaller (5.4 ± 1.8 mm vs. 7.8 ± 2.8 mm) in the hydrogel group. Histopathological findings revealed the inflammatory cell count was significantly higher in the control group. Our novel hydrogel showed a protective effect on artificial gastric ulcers in a rat model.

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Gastroprotective Effects of Methanolic Leaves and Stem Extracts of Sphagneticola trilobata on Indomethacin-Induced Gastric Ulcer in Rats

Asian Journal of Chemistry ◽

10.14233/ajchem.2022.23440 ◽

2021 ◽

Vol 34 (1) ◽

pp. 111-117

Author(s):

Kartik Singhal ◽

Chandana Majee ◽

Bhavani Pentela ◽

Vikas Sharma

Keyword(s):

Gastric Ulcer ◽

South America ◽

Medicinal Plant ◽

Protective Effect ◽

Folk Medicine ◽

Gastric Ulcers ◽

Control Group ◽

Methanolic Extracts ◽

Neutrophil Percentage ◽

Stem Extract

The medicinal plant Sphagneticola trilobata native to South America is used in local folk medicine to treat inflammation and analgesics. In present study, gastroprotective effects of methanolic extracts of S. trilobata leaves and stem were investigated in indomethacin-induced gastric ulcers in rats at doses of 200 mg/kg for leave extract and 350 mg/kg for stem extract. Indomethacin produced stomach ulcers and increased neutrophil percentage and MDA levels compared to the control group (p < 0.001). Co-administration of indomethacin and omeprazole, methanolic extracts of leaves (200 mg/kg) (p < 0.001) and methanolic extracts (350 mg/kg) (p < 0.05) of stem compared to indomethacin group to ulcers was low (p < 0.001). Methanolic extracts (200 mg/kg) of leaves and methanolic extracts (350 mg/kg) of stem reduced MDA levels (p < 0.001). Methanolic extracts (200 mg/kg) of leaves and methanolic extracts (350 mg/kg) of the stem significantly decreased neutrophil percentage compared to indomethacin group (p < 0.001). The results suggest that the methanolic extracts of Sphagneticola trilobata leaves and stem have a protective effect on indomethacin-induced gastric ulcers.

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Protective Effect of Boswellic Resin Against Memory Loss and Alzheimer’s Induced by Aluminum Tetrachloride and D-Galactose (Experimental study in Mice)

Phytothérapie ◽

10.3166/phyto-2020-0222 ◽

2020 ◽

Author(s):

K. Zerrouki ◽

N. Djebli ◽

L. Gadouche ◽

I. Erdogan Orhan ◽

F. SezerSenol Deniz ◽

...

Keyword(s):

Chemical Composition ◽

Protective Effect ◽

Cell Damage ◽

Memory Loss ◽

Control Group ◽

Total Extract ◽

Swiss Mice ◽

Octyl Acetate

Nowadays, because of the industrialization, a lot of contaminant were available ; the consequences of this availability are apparition of diseases including neurodegeneration. Neurodegenerative diseases of the human brain comprise a variety of disorders that affect an increasing percentage of the population. This study is based on the effect of the Boswellic resin, which is from a medicinal plant and known for its antioxidant effects on nerve cell damage. The objective of this work was to evaluate the in vitro and in vivo effects of the Boswellic resin on anticholinesterase activity and Alzheimer’s disease (AD) induced by D-galactose and aluminum tetrachloride in Swiss mice. Chemical composition of the resin essential oil was identified by the CG-MS analysis. The antioxidant activity was also assessed by the DMPD and metal chelation methods. In order to understand the mechanism of memory improvement, the acetylcholinesterase, AChE, and butyrylcholinesterase, BChE, inhibitory assays were performed. In vivo part of the study was achieved on Swiss mice divided into four groups: control, AD model, treated AD, and treated control group. The identification of chemical composition by CG-MS reach the 89.67% of the total extract compounds presented some very important molecules (p-Cymene, n-Octyl acetate, α-Pinene…). The present study proves that Boswellic resin improves memory and learning in treated Alzheimer’s group, modulates the oxidative stress and be involved in the protective effect against amyloid deposition and neurodegeneration, and stimulates the immune system in mice’s brain.

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Gastrointestinal Protective Effect of Zizyphus xylopyrus (Retz) Willd Leaf Extract Against Indomethacin and HCl-EtOH Induced Ulcers

Current Traditional Medicine ◽

10.2174/2215083804666181012124047 ◽

2019 ◽

Vol 5 (2) ◽

pp. 140-146

Author(s):

Shweta Jain ◽

Sourabh Jain ◽

Nagendra S. Chauhan ◽

Ankur Vaidya

Keyword(s):

Protective Effect ◽

Ethanolic Extract ◽

Negative Control ◽

Gastric Epithelium ◽

Gastric Ulcers ◽

Western India ◽

Skin Infections ◽

Ulcer Index ◽

Digestive Disorders ◽

North Western

Background: Zizyphus xylopyrus (Retz.) Willd. (Rhamnaceae) is a straggling shrub or a small tree, armed with spines, found throughout north western India, Pakistan and China. Methods: The aerial and root barks, leaves and fruits of Zizyphus species are used in medicine for the treatment of various diseases such as weakness, liver complaints, obesity, diabetes, skin infections, fever, diarrhea, insomnia and digestive disorders. Ethanolic extract of leaves of Zizyphus xylopyrus (Retz) Willd was prepared by solvent extraction and subjected to study the protective effect against Indomethacin and HCl-EtOH induced ulcer using Ranitidine (100 mg/kg) and Omeprazole (8 mg/kg) as standard respectively. Results: Histopathological lesions with marked disorientation of the gastric epithelium was observed in negative control, while extract treated rats showed a better protected mucosa with intact epithelium in comparison to standard treated rats. Ulcer index and percentage ulcer protection also represent protecting effects of the extract. Conclusion: Ethanolic extract of Z. xylopyrus (Retz) Willd leaves extract was found to be significantly protective against gastric ulcers.

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Personalized Behavioral Nutrition Intervention in Older Asian Americans with Type 2 Diabetes during COVID-19 Pandemic: Study Protocol for a Pilot, Hybrid, Randomized Controlled Trial (Preprint)

10.2196/preprints.23522 ◽

2020 ◽

Author(s):

Jisook Ko ◽

Yan Du ◽

Rozmin Jiwani ◽

Chengdong Li ◽

Jing Wang

Keyword(s):

Type 2 Diabetes ◽

Clinical Trials ◽

Pilot Study ◽

Glycemic Control ◽

Asian Americans ◽

Control Group ◽

Management Approach ◽

Self Monitoring ◽

Behavioral Nutrition

BACKGROUND The COVID-19 pandemic has challenged the in-person-based self-management approach (i.e., face-to-face or group approach) of type 2 diabetes (T2D). Older adults with T2D, including Asian Americans (AAs), have experienced worsening of diabetes control due to various reasons, including uncertainty of continuous access to essential diabetes medications, devices, education, limited health literacy, as well as constant anxiety and stress. Hybrid clinical trials that incorporate virtual elements into the in-person-based study could provide these vulnerable populations with accessible and timely interventions OBJECTIVE The primary aims of this pilot study are to determine (1) the effect of personalized behavioral nutrition (PBN) intervention on glycemic control, weight control, and metabolites profiles; and (2) the acceptability of PBN. to enhance glycemic control using personalized behavioral nutrition. METHODS Participants will be recruited with a web-based registry, advertisements in ethnic newspapers, and social network services popular among AAs. A total of 60 AAs, aged 65 years or older, who are descendants of Chinese, Korean, or South Asian, and have a diagnosis of T2D will be randomized into two groups: a PBN group (n=30) and a control group (n=30). A 4-week PBN intervention comprises three components: 1) digital self-monitoring; 2) personal nutrition change goals and recommendations; and 3) diabetes nutrition educations. All participants will complete digital self-monitoring on diet, physical activity, and blood glucose. In addition, all participants will access an interactive digital platform to track their self-monitoring data and communicate with the research team. The effectiveness and acceptability of implementing the intervention will be assessed. RESULTS Funding support and institutional review board approval for this study have been secured. Data collection started in August 2020 and is ongoing. CONCLUSIONS To our knowledge, this is the first study to determine the effectiveness and acceptability of PBN utilizing a metabolomics approach and digital-assisted intervention with hybrid RCT among older AAs. The findings of this pilot study will inform the development of a full-scale PBN protocol and hybrid clinical trials that can be adapted for people with T2D in the ongoing pandemic.

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AB0007 STAT4 RS7574865 G/T POLYMORPHISM AS MARKER OF PREDISPOSITION TO SYSTEMIC LUPUS ERYTHEMATOSUS WITH JUVENILE ONSET

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.2142 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 1038.2-1039

Author(s):

M. Kaleda ◽

M. Krylov ◽

I. Nikishina

Keyword(s):

Systemic Lupus Erythematosus ◽

Pilot Study ◽

Lupus Erythematosus ◽

Renal Involvement ◽

Control Group ◽

Coombs Test ◽

Systemic Lupus ◽

Direct Coombs Test ◽

Positive Direct ◽

Cutaneous Lupus

Background:Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with a significant genetic predisposition. Recent studies have identified STAT4 (signal transducers and transcription activators 4) as a susceptibility gene for SLE.Objectives:To investigate the hypothesis of the association of STAT4 rs7574865 G/T polymorphism with the predisposition to SLE in children and its relationship with some of SLE manifestations.Methods:The case-control pilot study included 143 children (39 with SLE and 103 healthy unrelated volunteers as a control group). Diagnosis of SLE was based on 2012 SLICC criteria. STAT4 rs7574865 G/T polymorphism was investigated using allele-specific real-time polymerase chain reaction (RT-PCR).Results:The group of pts with SLE consisted of 29 girls and 10 boys, with an average age of 11.8±3.7 years (from 3 to 17 years) and an average disease duration of 4.1±2.4 years. 79.5% pts had acute cutaneous lupus at the onset, 46.1% - nonscarring alopecia, 71.8% - arthritis, 23.1% - oral and nasal ulcers, 23.1% - serositis, 43.6% - renal involvement, 35.9% –neuropsychiatric disorders. Leucopenia/lymphopenia was found in 71.8% of pts, thrombocytopenia – in 23,1%. ANA were detected in 100% pts, anti-dsDNA – in 79.5%, anti-Sm – in 31.6%, antiphospholipid antibodies - in 7,3%, hypocomplementemia – in 61.5%, positive direct Coombs test – in 35.9 %. Macrophage activation syndrome at the onset was documented in 15.4 % of pts. The distribution of rs7574865 genotypes in the control group showed no significant deviations from the Hardy-Weinberg equilibrium. The distribution of genotype frequencies among pts had statistically significant differences compared to the control (χ2=12.95, p=0.0015): GG-30.8% and 63.1% (p=0.001), GT-56.4% and 33.0% (p=0.018), TT-12.8% and 3.9% (p=0.114), GT+TT - 69.2% and 36.9% (p=0.0005). The frequency of the mutant STAT 4 allele T (polymorphism), was significantly higher in the SLE group than in the control group (41% and 20.4%, respectively; p=0.0007). We identified an association of the T allele with some clinical, laboratory, and immunological disorders in SLE: arthritis (OR 3.9, p=0.0002), acute cutaneous lupus (OR 2.47, p=0.003), nonscarring alopecia (OR 3.12, p=0.002), renal involvement (OR 2.42, p=0.022), leucopenia (OR 2.72, p=0.003), thrombocytopenia (OR 4.88, p=0.002), anti-dsDNA (OR 2.82, p=0.0006), hypocomplementemia (OR 2.34, p=0.012), positive direct Coombs test (OR 3.38, p=0.002).Conclusion:Our pilot study confirmed that the STAT4 rs7574865 G/T polymorphism was associated with the risk of SLE in children and some of SLE manifestations.Disclosure of Interests:None declared

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FRI0617-HPR GRADED MOTOR IMAGERY IN POSTTRAUMATIC STIFFNESS OF THE ELBOW: A PILOT STUDY

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.2660 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 913.2-914

Author(s):

T. Birinci ◽

E. Kaya Mutlu ◽

S. Altun

Keyword(s):

Pilot Study ◽

Motor Imagery ◽

Upper Limb ◽

Exercise Program ◽

Control Group ◽

Elbow Fracture ◽

Stiff Elbow ◽

Limb Fractures ◽

Upper Limb Fractures ◽

Graded Motor Imagery

Background:Elbow fracture is treated either conservatively or surgically followed by a period of immobilization with casting or splinting. A splint used to immobilize upper limbs for many weeks results in changes in both the peripheral musculature and the central nervous system. It is well known that common complaints after upper limb fractures include weakness, pain, and stiffness; therefore, pain management is important in the early stages of the rehabilitation of upper limb fractures.Objectives:This pilot study aimed to investigate the efficacy of graded motor imaginary (GMI) on pain, range of motion (ROM), and function in patients with posttraumatic stiff elbow.Methods:Fourteen patients with posttraumatic stiff elbow (6 women, mean age: 45.42 ± 11.26 years, mean body mass index: 24.29 ± 3.38 kg\m2and mean duration of immobilization: 4.75 ± 1.03 weeks) were randomly allocated to either GMI or control groups. The GMI group received GMI treatment in addition to a structured exercise program, and the control group received a structured exercise program (two days per week for six weeks) (Figure 1). The assessments included pain at rest and during activity using the visual analog scale (VAS), elbow active ROM with a digital goniometer (Baseline Evaluation Instrument, Fabrication Enterprises, Inc., White Plains, NY), and upper extremity functional status using the Disability of the Arm, Shoulder and Hand Questionnaire (DASH). The assessments were performed at baseline and after the 6-week intervention.Figure 1.Graded motor imagery performed with mirror boxResults:After the 6-week intervention, there was a significant increase in elbow flexion-extension ROM and supination-pronation ROM, and improvement in DASH score in both groups (p<0.05). However, improvement in VAS-rest and VAS-activity was significantly higher in the GMI group than the control group (p=0.03 and p=0.01, respectively).Conclusion:A conservative treatment program consisting of GMI treatment in addition to a structured exercise program applied twice a week for 6 weeks, has been found more effective in decreasing pain in the posttraumatic stiff elbow. It could be concluded that GMI is an effective treatment method for elbow fracture in patients with predominant elbow pain.References:[1] Harris JE, Hebert A. Utilization of motor imagery in upper limb rehabilitation: a systematic scoping review. Clin Rehab. 2015:29(11):1092-1107.[2] Opie GM, Evans A, Ridding MC, Semmler JG. Short-term immobilization influences use-dependent cortical plasticity and fine motor performance. Neuroscience. 2016:330:247-256.[3] Birinci T, Razak Ozdincler A, Altun S, Kural C. A structured exercise programme combined with proprioceptive neuromuscular facilitation stretching or static stretching in posttraumatic stiffness of the elbow: a randomized controlled trial. Clin Rehab. 2019:33(2):241-252.Acknowledgments:The present work was supported by the Scientific Research Projects Coordination Unit of Istanbul University-Cerrahpasa (Project No: TDK-2019-33997).Disclosure of Interests:None declared

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Parental Self-Efficacy to Promote Children’s Healthy Lifestyles: A Pilot and Feasibility Study

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18094794 ◽

2021 ◽

Vol 18 (9) ◽

pp. 4794

Author(s):

Cayetana Ruiz-Zaldibar ◽

Inmaculada Serrano-Monzó ◽

Olga Lopez-Dicastillo ◽

María Jesús Pumar-Méndez ◽

Andrea Iriarte ◽

...

Keyword(s):

Pilot Study ◽

Parenting Styles ◽

Self Efficacy ◽

Parenting Practices ◽

Healthy Lifestyle ◽

Intervention Group ◽

Positive Parenting ◽

Parenting Programs ◽

Control Group ◽

Healthy Lifestyles

Positive parenting programs are a key strategy to promote the development of parental competence. We designed a pilot study based on parental self-efficacy to promote healthy lifestyles in their children aged between 2 to 5 years old. In this pilot study, we aimed to assess the effects of a parenting program on parental self-efficacy and parenting styles. Twenty-five parents were allocated into intervention (N = 15) and control group (N = 10). Parents from the intervention group received four group sessions (120 mi per session) to develop a positive parenting, parenting styles and parenting skills regarding to children’s diet, exercise, and screen time, and two additional sessions about child development and family games. Parents from the control group received these two latter sessions. Parental self-efficacy, parenting styles, and meal-related parenting practices were measured before and after the intervention and at 3-month follow-up. Acceptability and feasibility of the program was also measured. Quantitative data were analyzed using the repeat measures ANOVA and ANCOVA tests and the effect size calculation. Content analysis was used to analyse open questions. Positive trends were found regarding parental self-efficacy and the use of authoritative parenting style. Parents also reported a great acceptability of the program getting high satisfaction. According to the feasibility barriers and facilitators aspects were identified. The positive trends founded in this study support the development of parenting programs to promote healthy lifestyle in children.

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Nurse-based secondary preventive follow-up by telephone reduced recurrence of cardiovascular events: a randomised controlled trial

Scientific Reports ◽

10.1038/s41598-021-94892-0 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Anna-Lotta Irewall ◽

Anders Ulvenstam ◽

Anna Graipe ◽

Joachim Ögren ◽

Thomas Mooe

Keyword(s):

Randomised Controlled Trial ◽

Primary Endpoint ◽

Cardiovascular Events ◽

Controlled Trial ◽

Control Group ◽

Coronary Syndrome ◽

Secondary Endpoints ◽

Randomised Controlled

AbstractEnhanced follow-up is needed to improve the results of secondary preventive care in patients with established cardiovascular disease. We examined the effect of long-term, nurse-based, secondary preventive follow-up by telephone on the recurrence of cardiovascular events. Open, randomised, controlled trial with two parallel groups. Between 1 January 2010 and 31 December 2014, consecutive patients (n = 1890) admitted to hospital due to stroke, transient ischaemic attack (TIA), or acute coronary syndrome (ACS) were included. Participants were randomised (1:1) to nurse-based telephone follow-up (intervention, n = 944) or usual care (control, n = 946) and followed until 31 December 2017. The primary endpoint was a composite of stroke, myocardial infarction, cardiac revascularisation, and cardiovascular death. The individual components of the primary endpoint, TIA, and all-cause mortality were analysed as secondary endpoints. The assessment of outcome events was blinded to study group assignment. After a mean follow-up of 4.5 years, 22.7% (n = 214) of patients in the intervention group and 27.1% (n = 256) in the control group reached the primary composite endpoint (HR 0.81, 95% CI 0.68–0.97; ARR 4.4%, 95% CI 0.5–8.3). Secondary endpoints did not differ significantly between groups. Nurse-based secondary preventive follow-up by telephone reduced the recurrence of cardiovascular events during long-term follow-up.

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Cerebral oxygenation in 45-degree trendelenburg position for robot-assisted radical prostatectomy: a single-center, open, controlled pilot study

BMC Urology ◽

10.1186/s12894-020-00774-4 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Clemens Wiesinger ◽

Dominik Stefan Schoeb ◽

Mathias Stockhammer ◽

Emir Mirtezani ◽

Lukas Mitterschiffthaler ◽

...

Keyword(s):

Pilot Study ◽

Cerebral Oxygenation ◽

Preoperative Assessment ◽

Patient Characteristics ◽

Rank Test ◽

Control Group ◽

Robot Assisted ◽

Clinical Trial Registry ◽

Trendelenburg Position ◽

Signed Rank Test

Abstract Background Within the last decade, robotically-assisted laparoscopic prostatectomy (RALP) has become the standard for treating localized prostate cancer, causing a revival of the 45° Trendelenburg position. In this pilot study we investigated effects of Trendelenburg position on hemodynamics and cerebral oxygenation in patients undergoing RALP. Methods We enrolled 58 patients undergoing RALP and 22 patients undergoing robot-assisted partial nephrectomy (RAPN) (control group) in our study. Demographic patient data and intraoperative parameters including cerebral oxygenation and cerebral hemodynamics were recorded for all patients. Cerebral function was also assessed pre- and postoperatively via the Mini Mental Status (MMS) exam. Changes in parameters during surgery were modelled by a mixed effects model; changes in the MMS result were evaluated using the Wilcoxon signed rank test. Results Preoperative assessment of patient characteristics, standard blood values and vital parameters revealed no difference between the two groups. Conclusions Applying a 45° Trendelenburg position causes no difference in postoperative brain function, and does not alter cerebral oxygenation during a surgical procedure lasting up to 5 h. Further studies in larger patient cohorts will have to confirm these findings. Trial registration German Clinical Trial Registry; DRKS00005094; Registered 12th December 2013—Retrospectively registered; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00005094.

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The Effect of Reflexology on Lactation in Women Who Had Cesarean Section: A Randomized Controlled Pilot Study

Complementary Medicine Research ◽

10.1159/000513924 ◽

2021 ◽

pp. 1-8

Author(s):

Sevde Aksu ◽

Pelin Palas Karaca

Keyword(s):

Pilot Study ◽

Cesarean Section ◽

Intervention Group ◽

Control Group ◽

Breast Pain ◽

Randomized Controlled ◽

Significant Difference ◽

The Right ◽

Documentation Tool ◽

And Control

Aim: The research was conducted as a randomized controlled pilot study to evaluate the effects of reflexology on lactation in mothers who delivered by cesarean section (CS). Methods: A single-blind randomized controlled experimental study was conducted with a total of 60 postpartum women in the reflexology application (n = 30) and control groups (n = 30). After the CS, the mothers in the control group were given approximately 3-h routine nursing care after recovering from the effects of anesthesia; the introductory information form was applied, and the Breastfeeding Charting System and Documentation Tool (LATCH) and visual analog scale (VAS) for the signs of the onset of lactation were implemented on the first and second days. Reflexology was applied to the women in the intervention group after an average of 3 h following the mother’s condition had become stable and she had recovered from the effects of anesthesia. Reflexology was applied a total of 20 min – 10 min for the right foot, 10 min for the left foot – twice a day with 8-h intervals on the first and second days after CS. After the last reflexology application, the LATCH and VAS for the signs of the onset of lactation were applied. Results: Of the women, 70% breastfed their babies within 60 min after delivery; 46.7% of the mothers received breastfeeding training and 81.7% needed support for breastfeeding after the CS. The LATCH breastfeeding scores of the women in the intervention group on both days were significantly higher compared to those of the women in the control group (p < 0.001). On the first day after the CS, apart from breast pain, there was no significant difference between the two groups in terms of breast heat and breast tension (p > 0.05). On the second day after the CS, apart from breast tension, there was no significant difference between the groups in terms of breast heat and breast pain (p < 0.05). In the study, women in the intervention group were found to have higher scores in terms of all three symptoms compared to the control group (p < 0.05). Conclusions: In the study, it was determined that LATCH scores and signs of the onset of breastfeeding increased in the mothers who received reflexology after CS.

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