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临床试验/NCT07402785
NCT07402785
已完成
不适用

The Effect of Abdominal Massage on Constipation in Patients Receiving Hemodialysis Treatment

Firat Tukenmez1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2025年6月2日最近更新:
干预措施abdominal massage

概览

阶段
不适用
状态
已完成
发起方
Firat Tukenmez
入组人数
49
试验地点
1
主要终点
Constipation Severity

概览

简要总结

This study aimed to determine the effect of abdominal massage on constipation in patients undergoing hemodialysis. The main questions he intends to answer are:

H0: Abdominal massage applied to patients undergoing hemodialysis treatment has no effect on constipation. H1: Abdominal massage applied to patients receiving hemodialysis treatment has an effect on constipation.

详细描述

Participants and Setting The study population consisted of patients receiving hemodialysis treatment at the Dialysis Units of Rize Training and Research Hospital and Rize State Hospital. A total of 50 patients who met the inclusion criteria and did not meet any exclusion criteria were included in the study.

Eligible patients (n = 50) were listed and randomly assigned to either the intervention group (n = 25) or the control group (n = 25) using a simple randomization method via a computer-based program (https://randomizer.org/). One patient in the intervention group died one month after the initiation of the study, and the intervention was discontinued for this patient. Consequently, the study was completed with 49 patients (intervention group, n = 24; control group, n = 25).

Intervention and Control Prior to the study, the researcher completed a structured training program consisting of 16 hours of theoretical education and 24 hours of practical training provided by the Department of Physical Therapy and Rehabilitation at Rize Training and Research Hospital. An official certificate confirming completion of this training was issued by the hospital administration.

Abdominal massage was administered to the intervention group during hemodialysis sessions in the dialysis units of the respective hospitals, without interrupting the treatment process. Patient privacy was ensured using a curtain before each session. Massage was applied at least 30 minutes after meals. Before each session, patients' general physical and mental condition, vital signs, abdominal tension/sensitivity, and skin integrity were assessed.

Abdominal massage was performed by the researcher twice weekly for six weeks, with each session lasting 15 minutes, for a total of 12 sessions. At the end of the sixth week, the effectiveness of the intervention was evaluated using the Bristol Stool Form Scale, Constipation Severity Scale, and Constipation Quality of Life Questionnaire, administered face-to-face by the researcher.

The control group did not receive abdominal massage and continued their routine treatment. In both groups, outcome measures were assessed at baseline (first week) and at the end of the study period (sixth week).

Statistical Analysis Data were analyzed using the Statistical Package for the Social Sciences (SPSS) for Windows, version 26.0. Distribution characteristics were assessed using skewness and kurtosis values, all of which ranged between -2 and +2, indicating normal distribution. Descriptive statistics (frequency, percentage, mean, median, and standard deviation) were used. Independent t-tests were employed for between-group comparisons, paired t-tests for within-group comparisons, and the chi-square test for categorical variables. Parametric statistical methods were applied, and a p-value < 0.05 was considered statistically significant.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Aged 18 years or older
  • Voluntarily agreed to participate in the study
  • Receiving hemodialysis treatment for at least one month
  • Diagnosed with constipation by a clinician or meeting Rome IV criteria
  • Able to communicate effectively and respond to all study-related questions, either personally or through a caregiver

排除标准

  • History of ileus or intestinal perforation
  • Presence of abdominal distension
  • Presence of a colostomy or ileostomy
  • Presence of extensive abdominal skin disease or infection
  • Diagnosis of inflammatory bowel disease
  • Presence of signs or symptoms of an acute abdomen
  • Presence of diarrhea
  • Known allergy to baby oil
  • Refusal to participate in the study

研究组 & 干预措施

control group (n = 25)

No Intervention

The control group did not receive abdominal massage and continued their routine treatment. In groups, outcome measures were assessed at baseline (first week) and at the end of the study period (sixth week). For evaluation Bristol Stool Form Scale, Constipation Severity Scale, and Constipation Quality of Life Questionnaire, administered face-to-face by the researcher.

intervention group (n = 24)

Experimental

One patient in the intervention group died one month after the initiation of the study, and the intervention was discontinued for this patient.Abdominal massage was administered to the intervention group during hemodialysis sessions in the dialysis units of the respective hospitals, without interrupting the treatment process. Patient privacy was ensured using a curtain before each session. Massage was applied at least 30 minutes after meals. Before each session, patients' general physical and mental condition, vital signs, abdominal tension/sensitivity, and skin integrity were assessed.

Abdominal massage was performed by the researcher twice weekly for six weeks, with each session lasting 15 minutes, for a total of 12 sessions. At the end of the sixth week, the effectiveness of the intervention was evaluated using the Bristol Stool Form Scale, Constipation Severity Scale, and Constipation Quality of Life Questionnaire, administered face-to-face by the researcher.

干预措施: abdominal massage (Other)

结局指标

主要结局

Constipation Severity

时间窗: baseline and end of week 6

change in constipation severity measured using the Constipation Severity Scale

次要结局

  • Constipation-related Quality of Life(Baseline and end of week 6)
  • Stool Consistency(Baseline and end of week 6)

研究者

发起方
Firat Tukenmez
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Firat Tukenmez

NURSE

Karadeniz Technical University

研究点 (1)

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