- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06875349
Foot Reflexology and Abdominal Massage (experimental)
The Effects of Foot Reflexology and Abdominal Massage in Elderly on Constipation: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Trabzon, Turkey
- Karadeniz Technical University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Being 65 years or older Having no movement restrictions Not using pharmacological laxatives Being diagnosed with constipation according to the ROMA IV criteria Voluntarily agreeing to participate in the study
Exclusion Criteria:
Individuals having a condition that prevents cognitive, affective and verbal communication Having a disorder related to the nervous system and circulatory system Having an injection applied to the abdominal region during the application process Having a systematic disorder related to the GIS (diarrhea, irritable bowel syndrome, fecal impaction, incontinence, etc.) Having physiological and structural disorders that may prevent evacuation in the anus region (rectal fissure, etc.) Having any negativity in the sensory function examination test performed with a sharp-blunt hard object on the sole of the foot and abdomen Having any physiological and structural disorders related to the foot/sole of the foot
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Group 1: Foot Reflexology
In the experimental group-1, foot reflexology interventions were applied every three days, with each session lasting 30 minutes, for a total of eight sessions.
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Foot reflexology is a complementary therapy that involves applying pressure to specific points on the feet, which are believed to correspond to different organs and systems in the body.
This technique aims to promote healing by improving blood circulation, reducing stress, and supporting overall well-being.
Reflexology is often used to help with issues such as constipation, stress, sleep disorders, and pain management.
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Experimental: Group 2: Abdominal Massage
In the experimental group-2, abdominal massage interventions were applied every three days, with each session lasting 30 minutes, for a total of eight sessions.
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Abdominal massage is a therapeutic technique that involves applying gentle pressure and circular motions to the abdominal area to stimulate digestion, improve bowel movements, and relieve discomfort.
It is commonly used to help with issues such as constipation, bloating, and digestive disorders by promoting intestinal motility and blood circulation.
This technique can be performed manually or with the help of tools and is often incorporated into holistic and nursing care practices.
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No Intervention: Group 3: Control
The elderly individuals in the control group did not receive any intervention and were only monitored.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Constipation Severity Scale
Time Frame: Day 1 and Day 13 and Day 25
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Does foot reflexology have an effect on constipation in elderly individuals?
Constipation Severity Scale: The total score range is 0-73, with higher scores indicating greater severity of constipation.
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Day 1 and Day 13 and Day 25
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Constipation Severity Scale
Time Frame: Day 1 and Day 13 and Day 25
|
Does abdominal massage have an effect on constipation in elderly individuals?
Constipation Severity Scale: The total score range is 0-73, with higher scores indicating greater severity of constipation.
|
Day 1 and Day 13 and Day 25
|
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Constipation Severity Scale
Time Frame: Day 1 and Day 13 and Day 25
|
Is there a difference between the effects of foot reflexology and abdominal massage on constipation in elderly individuals?
Constipation Severity Scale: The total score range is 0-73, with higher scores indicating greater severity of constipation.
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Day 1 and Day 13 and Day 25
|
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-KAEK-80-23-30
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
product manufactured in and exported from the U.S.
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