NCT07437014

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
21mo left

Started Feb 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress16%
Feb 2026Mar 2028

First Submitted

Initial submission to the registry

February 20, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

February 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

March 4, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

February 20, 2026

Last Update Submit

March 1, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • constipation risk assessment

    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.

    baseline (day 0)

  • Occurrence of postoperative constipation

    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 Days 1-15

  • Postoperative Constipation Severity

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

    postoperative daily from Day 1 to Day 15"

  • classify faeces

    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

    Postoperative Days 1-15

Secondary Outcomes (1)

  • quality of recovery

    postoperative day 15

Study Arms (3)

Abdominal massage and warm water consumption group

ACTIVE COMPARATOR
Behavioral: ABDOMINAL MASSAGE AND WARM WATER CONSUMPTION

abdominal massage group

ACTIVE COMPARATOR
Other: abdominal massage

Control group

PLACEBO COMPARATOR
Other: Control (Standard treatment)

Interventions

The effect of abdominal massage and warm water consumptione on postoperative constipation.

Abdominal massage and warm water consumption group

abdominal massage on postoperative constipation.

abdominal massage group

standart protocol on the development of postoperative constipation

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

melek sarı, PhD Candidate

CONTACT

Zeliha Özdemir Köken, Doçent Dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 20, 2026

First Posted

February 27, 2026

Study Start

February 20, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2028

Last Updated

March 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share