NCT06788392

Brief Summary

The Effect of Reminiscence Therapy on Constipation Applied to Elderly Individuals Staying in a Nursing Home in Giresun Province

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2025

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

December 2, 2024

Last Update Submit

February 15, 2025

Conditions

Keywords

the elderlyconstipationcomfortreminiscence therapy

Outcome Measures

Primary Outcomes (3)

  • Constipation Severity Scale (CSS) General Comfort

    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)

    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

    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)

Study Arms (2)

interventional

EXPERIMENTAL

Group receiving reminiscence therapy 2 days a week

Other: reminiscence therapy

control

NO INTERVENTION

The group in which no intervention and receiving routine nursing care

Interventions

Reminiscence Therapy is a supportive care model that has been used in recent years and increases life comfort.

interventional

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Giresun Huzurevi Yaşli Bakim Ve Rehabilitasyon Merkezi

Giresun, Merkez, 28000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
In the study, blinding will be performed only in the assignment-randomisation to groups and statistical analysis of the results.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Block randomisation will be used to ensure that the number of patients in each group is balanced. Patients will be divided into two groups, each group consisting of at least 38 people, by a statistician who is not involved in the study, using a table of random numbers.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

December 2, 2024

First Posted

January 23, 2025

Study Start

September 1, 2024

Primary Completion

January 12, 2025

Study Completion

February 1, 2025

Last Updated

February 19, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

It is the request of the individuals who participated in my study.

Locations