ConstipationNCT06788392
Nursing Homes on Constipation and General Comfort
A study testing reminiscence therapy in people with Constipation and Nursing Caries, run by Giresun Huzurevi Yaşlı Bakım ve Rehabilitasyon Merkezi at 1 site in Turkey (Türkiye).
Trial summary
The Effect of Reminiscence Therapy on Constipation Applied to Elderly Individuals Staying in a Nursing Home in Giresun Province Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Constipation, Nursing Caries
- What is being tested?
- reminiscence therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Giresun Huzurevi Yaşli Bakim Ve Rehabilitasyon Merkezi
Giresun, Merkez, 28000
About this study
Official title: 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
Read the 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.
- Conditions
- Constipation, Nursing Caries
- Being tested
- reminiscence therapy
- Keywords
- the elderly, constipation, comfort, reminiscence therapy
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reminiscence therapyOther
Reminiscence Therapy is a supportive care model that has been used in recent years and increases life comfort.
| Study group | Role | What they receive |
|---|---|---|
| interventional | Experimental | Group receiving reminiscence therapy 2 days a week Receives: Other: reminiscence therapy |
| control | No intervention | The group in which no intervention and receiving routine nursing care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Comfort levels will be measured at the begining of the study (pre-test) and end of the intervention of the 5 weeks (post test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start1 Sep 2024
- Primary completion12 Jan 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giresun Huzurevi Yaşlı Bakım ve Rehabilitasyon Merkezi
- Sponsor type
- Other government
- Collaborators
- Kafkas University
- Responsible party
- Principal investigator, KEVSER KASAP, Kafkas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788392
- Sponsor's protocol ID
- AIBU-SBF-KK-01
- Other IDs
- Kevser KASAP
- Status last verified
- Feb 2025
- First submitted
- 2 Dec 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is the request of the individuals who participated in my study.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reminiscence Therapy Applied to Elderly Individuals Staying in Nursing Homes on Constipation and General Comfort
- ClinicalTrials.gov ID
- NCT06788392
- Acronym / sponsor ID
- AIBU-SBF-KK-01
- Conditions
- Constipation, Nursing Caries
- Keywords
- the elderly, constipation, comfort, reminiscence therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Giresun Huzurevi Yaşlı Bakım ve Rehabilitasyon MerkeziOther government
- Collaborators
- Kafkas University
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 12 Jan 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Effect of Reminiscence Therapy on Constipation Applied to Elderly Individuals Staying in a Nursing Home in Giresun Province
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| interventional | Experimental | Other: reminiscence therapyGroup receiving reminiscence therapy 2 days a week |
| control | No intervention | –The group in which no intervention and receiving routine nursing care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reminiscence therapyReminiscence Therapy is a supportive care model that has been used in recent years and increases life comfort. | Other | interventional |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No. It is the request of the individuals who participated in my study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reminiscence therapy in people with Constipation and Nursing Caries, run by Giresun Huzurevi Yaşlı Bakım ve Rehabilitasyon Merkezi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.