- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07437014
The Effect of Abdomınal Massage and Warm Water Consumptıon on Postoperatıve Constıpatıon Development and Qualıty of Recovery in Patıents Undergoıng Hıp Fractures Surgery
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
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: melek sarı, PhD Candidate
- Phone Number: +905447133701
- Email: meleksari8195@hotmail.com
Study Contact Backup
- Name: Zeliha Özdemir Köken, Doçent Dr
- Phone Number: +905055866346
- Email: ozdemir.z@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control group
|
standart protocol on the development of postoperative constipation
|
|
Active Comparator: Abdominal massage and warm water consumption group
|
The effect of abdominal massage and warm water consumptione on postoperative constipation.
|
|
Active Comparator: abdominal massage group
|
abdominal massage on postoperative constipation.
|
What is the study measuring?
Primary Outcome Measures
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- E2-26-14078
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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