- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07521774
The Effect of Ho'Oponopono Technique on Ostomy Adjustment, Body Image, and Quality of Life
The Effect of Ho'Oponopono Technique on Ostomy Adjustment, Body Image and Quality of Life in Colostomy Patients: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey (Türkiye)
- Istanbul Basaksehir Cam and Sakura City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Scheduled to undergo colostomy
Aged 18 years or older
Able to speak and understand Turkish
Literate (able to read and write)
Willing to participate in the study
Exclusion Criteria:
Having communication problems
Having a neurological or psychiatric disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Ho'oponopono Technique Intervention
The Ho'oponopono technique will be applied to patients in the intervention group after surgery.
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Patients in the intervention group will receive the Ho'oponopono technique face to face from a certified nurse at 10:00 a.m. on the 1st, 2nd, and 3rd postoperative days, and they will be instructed to continue practicing this technique for 21 days.
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Active Comparator: Control Group (Standard Care)
No intervention will be performed for the patients in this group.
The scales to be used in the study will be administered within the same time frame as in the intervention group.
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Standard care is provided to individuals who have a stoma created in the postoperative period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Quality of Life as Assessed by the Stoma Quality of Life Scale (Stoma-QOL) Total Score
Time Frame: The Ho'oponopono technique will be applied on postoperative days 1, 2, and 3 at 10:00 a.m. and will continue until the end of the first month. Data will be collected using the study scales on days 1, 3, and 10, and at the end of the first month.
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Quality of life in individuals with an ostomy will be evaluated using the Baxter et al. Stoma Quality of Life Scale (Stoma-QOL), a standardized self-report questionnaire specifically developed for individuals with a stoma. The scale consists of 21 items that measure stoma-related quality of life. The first two items assess overall life satisfaction and are scored from 0 to 100, with higher scores indicating greater satisfaction. The remaining items evaluate three subdimensions: work and social life (6 items), sexuality and body image (5 items), and stoma function (6 items), and one item assesses perceived economic status. Item scores are summed and transformed according to the scoring manual to obtain a total score. The total Stoma-QOL score will be used as the single reported outcome, with higher scores indicating better quality of life. Score range: 0-100 Minimum: 0 Maximum: 100 Higher scores indicate better quality of life. |
The Ho'oponopono technique will be applied on postoperative days 1, 2, and 3 at 10:00 a.m. and will continue until the end of the first month. Data will be collected using the study scales on days 1, 3, and 10, and at the end of the first month.
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Ostomy Adjustment Level as Assessed by the Ostomy Adjustment Scale (OAS) Total Score
Time Frame: The Ho'oponopono technique will be applied on postoperative days 1, 2, and 3 at 10:00 a.m. and will continue until the end of the first month. Data will be collected using the study scales on days 1, 3, and 10, and at the end of the first month.
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Adaptation to living with an ostomy will be evaluated using the Ostomy Adjustment Scale, a Likert-type, self-report measurement tool that provides a quantitative assessment of overall ostomy adjustment. The scale includes items addressing physical adjustment (stoma care, pouch management, and ability to perform daily activities), psychological adjustment (acceptance of the ostomy, anxiety, body image, and self-esteem), social adjustment (participation in social relationships, comfort in social environments, and perceived stigma), and coping and adaptation skills (problem-solving, use of support resources, and managing daily life with an ostomy). Each item is scored on a Likert scale, and item scores are summed to obtain a total score. The total score will be used as the single reported outcome, with higher scores indicating better adjustment to the ostomy. Score range: 34-204 Minimum: 34 Maximum: 204 Higher scores indicate better adjustment to the ostomy. |
The Ho'oponopono technique will be applied on postoperative days 1, 2, and 3 at 10:00 a.m. and will continue until the end of the first month. Data will be collected using the study scales on days 1, 3, and 10, and at the end of the first month.
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Body Image Perception as Assessed by the Body Image Scale (BIS) Total Score
Time Frame: The Ho'oponopono technique will be applied on postoperative days 1, 2, and 3 at 10:00 a.m. and will continue until the end of the first month. Data will be collected using the study scales on days 1, 3, and 10, and at the end of the first month.
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Body image perception in individuals with an ostomy will be evaluated using the Body Image Scale, a self-report psychometric instrument that quantitatively measures satisfaction with body appearance and attitudes toward the body. The scale consists of Likert-type items assessing affective, cognitive, and behavioral responses related to body image. Each item is scored on a 4-point scale, and the item scores are summed to obtain a total score. The total score will be used as the single reported outcome. Higher scores indicate greater body image disturbance, whereas lower scores reflect a more positive body image perception. Score range: 0-30 Minimum: 0 Maximum: 30 Higher scores indicate poorer body image. |
The Ho'oponopono technique will be applied on postoperative days 1, 2, and 3 at 10:00 a.m. and will continue until the end of the first month. Data will be collected using the study scales on days 1, 3, and 10, and at the end of the first month.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- Ho'oponopono Technique
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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