- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06951022
The Effect of Sujok Therapy on Urinary Incontinence and Quality of Life in Postmenopausal Women
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Malatya
-
Battalgazi̇, Malatya, Turkey, 44280
- Inonu University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Women under 65 years of age in the postmenopausal period, Literate, No speech or communication impairment
Exclusion Criteria:
Use of diuretics
Presence of nephrotic syndrome
Diagnosis of diabetes or hypertension
Symptoms of urinary tract infection
Diagnosis of psychiatric illness
History of urinary tract surgery
Diagnosed urinary prolapse
Failure to complete the intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
standard care
|
|
|
Experimental: Intervention
Participants in the intervention group will receive seed therapy using apple seeds applied to specific hand points corresponding to the bladder area.
|
Participants in the intervention group will receive seed therapy using apple seeds applied to specific hand points corresponding to the bladder area.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in urinary incontinence symptoms measured by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
Time Frame: At baseline, 15 days and 30 days after intervention
|
Description: The ICIQ-SF is a 4-item questionnaire used to evaluate the severity and impact of urinary incontinence. Scoring: Scores range from 0 to 21, with higher scores indicating more severe urinary incontinence. Unit of Measure: Points on a scale |
At baseline, 15 days and 30 days after intervention
|
|
Change in quality of life measured by the Incontinence Quality of Life Scale (I-QOL)
Time Frame: At baseline, 15 days and 30 days after intervention
|
Description: The I-QOL assesses quality of life, including behavioral limitation, psychosocial impact, and social isolation, in postmenopausal women with urinary incontinence. Scoring: Domain scores range from 0 to 100, where higher scores represent a poorer quality of life. Unit of Measure: Total score (0-100) |
At baseline, 15 days and 30 days after intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
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
Additional Relevant MeSH Terms
- Urogenital Diseases
- Mental Disorders
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urination Disorders
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Behavioral Symptoms
- Elimination Disorders
- Urinary Incontinence
- Enuresis
Other Study ID Numbers
- 2024/5494
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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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