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临床试验/NCT07437014
NCT07437014尚未招募不适用

The Effect of Abdomınal Massage and Warm Water Consumptıon on Postoperatıve Constıpatıon Development and Qualıty of Recovery in Patıents Undergoıng Hıp Fractures Surgery: A Randomızed Comparatıve Study

Hacettepe University0 个研究点目标入组 81 人开始时间: 2026年2月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
81
主要终点
constipation risk assessment

研究概览

简要总结

There is a need for studies investigating the effects of abdominal massage and warm water consumption on the development of postoperative constipation and quality of recovery in patients who have undergone hip fracture surgery. The aim of the study is to investigate the effects of abdominal massage and warm water consumption on the development of postoperative constipation quality of recovery in patients who have undergone hip fracture surgery. The study will be conducted as a prospective, parallel, three-group (1:1:1) randomized controlled trial to determine the effect of abdominal massage alone versus standard care in preventing the development of postoperative constipation in patients who underwent surgery for hip fracture. The following instruments will be used to collect study data: "Patient Demographic Information Form", "Constipation Risk Assessment Scale" for determining the constipation risk group and for randomization, "Bristol Stool Scale" for determining the type of constipation, "Constipation Assessment Scale" for determining the severity of constipation, and "Quality of Recovery-40 Questionnaire". For data analysis, parametric (Independent Samples T-Test, ANOVA) or non-parametric tests (Mann-Whitney U, Kruskal-Wallis H) will be used for pairwise and multiple group comparisons, depending on the distribution of the data. The Chi-Square test will be used for categorical data, and logistic regression analysis will be performed to determine the effect of continuous variables obtained from constipation development status and patient follow-up on the development or absence of constipation.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being 18 years of age or older
  • Agreeing to participate in the study
  • Undergoing open surgical treatment due to a hip fracture classified as 31A, 31B, or 31C according to the AO/OTA classification
  • Initiation of postoperative oral feeding

排除标准

  • Communication problems (speech and hearing impairments)
  • Neurological and psychiatric problems such as Alzheimer's or dementia
  • Problems preventing abdominal massage (surgery, wound site)
  • Regular laxative use before surgery
  • Previous colon surgery - physiological and structural abnormalities in the anal region that may hinder bowel movements
  • Use of medications that reduce bowel motility before surgery (antipsychotics, antidepressants, etc.)
  • Diagnosis of chronic constipation made by a physician before surgery
  • Difficulty transitioning to oral feeding and inability to eat orally
  • Multiple traumas affecting mobilization in addition to a hip fracture
  • Surgery for hip fracture performed using a minimally invasive method

研究组 & 干预措施

Abdominal massage and warm water consumption group

Active Comparator

干预措施: ABDOMINAL MASSAGE AND WARM WATER CONSUMPTION (Behavioral)

abdominal massage group

Active Comparator

干预措施: abdominal massage (Other)

Control group

Placebo Comparator

干预措施: Control (Standard treatment) (Other)

结局指标

主要结局

constipation risk assessment

时间窗: baseline (day 0)

The following instruments will be used to collect study data: "Constipation Risk Assessment Scale" for determining the constipation risk group and for randomization. The overall score is categorized into three constipation risk groups: 1 through 10 refers to "low risk"; a score between 11 and 15 refers to "moderate risk"; and 16 and over indicates "high risk". Higher scores indicating more severe constipation risk factors.

Occurrence of postoperative constipation

时间窗: Postoperative Days 1-15

Postoperative constipation development will assessed based on the absence of bowel movement for ≥3 consecutive postoperative days. Higher frequency indicates greater occurrence of postoperative constipation. Participants meeting criteria (Yes/No)

Postoperative Constipation Severity

时间窗: postoperative daily from Day 1 to Day 15"

Postoperative constipation severity will assessed using the Constipation Severity Scale, which ranges from 0 to 16, with higher scores indicating more severe constipation.

classify faeces

时间窗: Postoperative Days 1-15

Postoperative stool type will be assessed using the Bristol Stool Scale, which ranges from 1 to 7. Type 1-2 indicate constipation, type 3-4 are ideal stools as they are easier to pass, and type 5-7 may indicate diarrhoea and urgency. A low score indicates constipation. The assessment will performed at each defecation during the postoperative period

次要结局

  • quality of recovery(postoperative day 15)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Melek Sarı

Principal Investigator

Hacettepe University

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