- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06788392
Nursing Homes on Constipation and General Comfort
February 15, 2025 updated by: KEVSER KASAP, Giresun Huzurevi Yaşlı Bakım ve Rehabilitasyon Merkezi
The Effect of Reminiscence Therapy Applied to Elderly Individuals Staying in Nursing Homes on Constipation and General Comfort
The Effect of Reminiscence Therapy on Constipation Applied to Elderly Individuals Staying in a Nursing Home in Giresun Province
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Research; This study will be conducted to determine the effect of reminiscence therapy, given once or twice a week to elderly people living in nursing homes, on constipation by reducing stress levels.
It is thought that the results obtained will provide evidence for reducing constipation, which significantly limits life.
Patients who complain of constipation at the Nursing Home Elderly Care and Rehabilitation Center, who voluntarily agree to participate in the research and who meet the sample selection criteria will be included in the study.
Patient information will be collected and the research pre-test, post-test and application will be carried out face to face.
Study Type
Interventional
Enrollment (Actual)
70
Phase
- 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 Locations
-
-
Merkez
-
Gi̇resun, Merkez, Turkey, 28000
- Giresun Huzurevi Yaşli Bakim Ve Rehabilitasyon Merkezi
-
-
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
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion criteria for the study:
- Those aged 65 and over,
- Able to answer all questions and be communicative,
- Scoring 24 or above from the Mini Mental test,
- Agreeing to participate in the research,
- Diagnosed with constipation by the institution physician and meeting the Rome III Constipation Diagnostic Criteria,
- There is no deterioration in skin integrity or infection in the abdominal area,
- No diarrhea,
- Individuals without a history of abdominal surgery will be included in the study.
Exclusion Criteria
- Psychiatric drug users,
- Those who score below 24 on the Mini Mental Test,
- Those who do not meet the Rome III Diagnostic Criteria for Constipation,
- Those with impaired skin integrity or infection in the abdominal area,
- People with diarrhoea,
- History of abdominal surgery Those who refused to participate in the study
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: interventional
Group receiving reminiscence therapy 2 days a week
|
Reminiscence Therapy is a supportive care model that has been used in recent years and increases life comfort.
|
|
No Intervention: control
The group in which no intervention and receiving routine nursing care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Constipation Severity Scale (CSS) General Comfort
Time Frame: Constipation levels will be measured at the begining of the study (pre-test) and end of the intervention of the 5 weeks (post test)
|
It was developed by Varma et al. in 2008.
It is a scale for determining the frequency, intensity and difficulty/difficulty during defecation.
|
Constipation levels will be measured at the begining of the study (pre-test) and end of the intervention of the 5 weeks (post test)
|
|
Defecation Monitoring Form in a Standard Diary (DMFSD)
Time Frame: Constipation status will be monitored at the beginning of the study and daily for 5 weeks
|
In the form developed by Pamuk et al. (2003) there is a 7-day follow-up schedule consisting of 5 items, including the number of defecation, the amount of stool, the stool consistency, the feeling of buckling during defecation and the feeling of not fully emptying after defecation.
For each symptom of constipation, all scores collected during the pre-treatment (7 days), sequence of application (21 days) and post-treatment (7 days) days were calculated by dividing the number of defecations performed within the same days.
|
Constipation status will be monitored at the beginning of the study and daily for 5 weeks
|
|
General Comfort Questionnaire
Time Frame: Comfort levels will be measured at the begining of the study (pre-test) and end of the intervention of the 5 weeks (post test)
|
It was developed by Kolcaba in 1992.
A validity and reliability study was conducted by Kuğuoğlu and Karabacak in 2004.
The General Comfort Scale is used to determine the comfort needs and to evaluate the state of achieving the result of increasing the expected comfort with the nursing interventions that constitute comfort, which includes three levels (relief, relaxation and superiority) and four dimensions (physical, psychospiritual, sociocultural and environmental) that constitute the theoretical factors of comfort.
|
Comfort levels will be measured at the begining of the study (pre-test) and end of the intervention of the 5 weeks (post test)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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 (Actual)
September 1, 2024
Primary Completion (Actual)
January 12, 2025
Study Completion (Actual)
February 1, 2025
Study Registration Dates
First Submitted
December 2, 2024
First Submitted That Met QC Criteria
January 18, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 15, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIBU-SBF-KK-01
- Kevser KASAP (Other Identifier: Giresun Nursıng Home Elderly Care And Rehabılıtatıon Center)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
It is the request of the individuals who participated in my study.
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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