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

March 1, 2026 updated by: Melek Sarı, Hacettepe University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
81

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control group
Other: Control (Standard treatment)
standart protocol on the development of postoperative constipation
Active Comparator: Abdominal massage and warm water consumption group
Behavioral: ABDOMINAL MASSAGE AND WARM WATER CONSUMPTION
The effect of abdominal massage and warm water consumptione on postoperative constipation.
Active Comparator: abdominal massage group
Other: abdominal massage
abdominal massage on postoperative constipation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
constipation risk assessment
Time Frame: 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.
baseline (day 0)
Occurrence of postoperative constipation
Time Frame: 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 Days 1-15
Postoperative Constipation Severity
Time Frame: 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.
postoperative daily from Day 1 to Day 15"
classify faeces
Time Frame: 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
Postoperative Days 1-15

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
quality of recovery
Time Frame: postoperative day 15
Quality of life was assessed using the Quality of Recovery-40 Questionnaire, which ranges from 40-200, with higher scores indicating better recovery of life.
postoperative day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E2-26-14078

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

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Conditions

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Dietary Supplements

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