- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07528534
Foot Reflexology and Acupressure on Gastrointestinal Symptoms (Menopausal)
The Effect of Foot Reflexology and Acupressure on Gastrointestinal Symptoms in Menopausal Women
This research was planned to evaluate the effects of foot reflexology and acupressure applications on gastrointestinal symptoms in women going through menopause. Menopause is a period in which a woman experiences profound changes in her physiological, psychological, and social life due to the decrease in estrogen and progesterone hormones. Changes in digestive system functions are particularly common during this period; gastrointestinal symptoms such as constipation, bloating, heartburn, indigestion, and abdominal pain significantly reduce the quality of life.
The scope of the study focuses on investigating the manageability of these symptoms that occur during menopause with reflexology and acupressure, which are complementary and alternative medicine methods. Reflexology is a method based on the assumption that specific points on the soles of the feet are connected to the relevant organs in the body, aiming to increase blood circulation and regulate organ functions. Acupressure, based on Chinese medicine, aims to regulate energy flow and reduce symptoms by applying finger pressure to specific acupuncture points. Both methods are increasingly recommended for symptom management during menopause due to their non-invasive nature, low side effects, and ease of application.
This research will be conducted at Osmaniye State Hospital and will be limited to menopausal women who apply to this institution. Participants' demographic characteristics, duration of menopause, health history, and gastrointestinal symptom levels will be assessed using a Demographic Information Form and the Gastrointestinal Symptom Rating Scale (GSRS). The application process will be carried out in accordance with standard reflexology and acupressure protocols, and changes in symptoms will be analyzed using pre-test and post-test measurements. The study also aims to reveal the effects of gastrointestinal symptoms experienced during menopause on women's quality of life; This study aims to provide evidence-based data on complementary methods that can be integrated into nursing care, in addition to pharmacological treatments. The limited number of studies in the literature addressing the effects of complementary medicine practices during menopause makes this research unique from both a clinical and academic perspective.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Menopause is a transitional period in which women experience profound changes in their physiological, psychological, and social lives due to the decrease in estrogen and progesterone hormones. During this process, significant changes are observed, particularly in digestive system functions, as a result of hormonal fluctuations. Gastrointestinal symptoms such as constipation, bloating, heartburn, indigestion, and abdominal pain, frequently encountered during menopause, significantly reduce women's daily activities and overall quality of life.
Intervention Methods and Mechanisms of Action
This research deeply examines the effectiveness of non-invasive, low-side-effect, and practically applicable complementary and alternative medicine methods in managing these gastrointestinal symptoms. The theoretical framework of two main interventions to be applied in this study is as follows:
Foot Reflexology: This is based on the principle that specific reflex points on the soles of the feet are directly connected to the relevant organs, glands, and systems in the body. Manipulations performed on these points according to standard protocols aim to increase blood circulation, relax the nervous system, and directly support the normal functions of the gastrointestinal system.
Acupressure: Based on the principles of traditional Chinese medicine, this method involves applying systematic pressure with the fingertips to specific acupuncture points to balance the flow of energy in the body. This stimulation aims to regulate nerve transmission, relieve spasms and blockages in the digestive system, and thus alleviate gastrointestinal complaints.
Clinical Significance and Contribution to the Literature While routine pharmacological treatments are common in the management of menopausal symptoms, there is a growing need for holistic approaches that can be integrated into these treatments and have no side effects. The limited number of studies in the literature examining the specific direct effects of complementary medicine practices on the gastrointestinal system and their impact on quality of life in menopausal women makes this study highly unique in terms of both clinical practice and academic literature. The findings of this research will contribute to the creation of evidence-based, independent, and effective nursing interventions that can be integrated into standard nursing care plans in addition to pharmacological methods.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being between 45 and 60 years of age,
- Being in menopause,
- Experiencing gastrointestinal symptoms,
- Agreeing to participate in the study voluntarily.
Exclusion Criteria:
- Individuals with chronic gastrointestinal disease,
- Individuals receiving regular medication will not be included in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: control
|
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Experimental: Acupressure
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Description: Menopausal women assigned to the acupressure group will receive a standardized acupressure protocol administered by a trained/certified practitioner. The steps and standards of the intervention are as follows: Preparation: The application will be conducted in a quiet, well-ventilated room with appropriate lighting and temperature to ensure the participant's comfort. The participant will be placed in a relaxed, comfortable position (supine or seated) that allows the practitioner easy access to the targeted acupressure points. Target Area Applications: The intervention involves applying physical pressure to specific acupuncture points based on Traditional Chinese Medicine principles to regulate energy flow (Qi) and alleviate gastrointestinal symptoms. The practitioner will focus on key acupoints known to support the stomach, intestines, and overall digestive system, as well as points that promote systemic relaxation and autonomic nervous system balance. Application Techni |
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Experimental: Foot Reflexology
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Menopausal women assigned to the foot reflexology group will receive a standardized reflexology protocol administered by a trained/certified researcher. The steps and standards of the intervention are as follows: Preparation: The application will be conducted in a quiet room with adjusted lighting and temperature. The participant will be positioned on a bed in a supine or semi-sitting position (approximately 45 degrees) with their legs supported. An unscented and non-allergenic massage oil or lotion will be used to reduce friction and maintain skin integrity. Warm-up and Relaxation: Before starting the specific procedure, a brief relaxation massage using effleurage and petrissage techniques will be applied to both feet to increase blood circulation and prepare the tissues. Target Area Applications: Following the warm-up, the focus will be directed to specific reflex points aimed at alleviating gastrointestinal symptoms, which is the primary objective of the study. Using thumb-walkin |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary Outcome Measure Change from Baseline in Gastrointestinal Symptom Scores as Measured by the Gastrointestinal Symptom Rating Scale (GSRS)
Time Frame: Baseline and Week 8 (8 weeks)
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Gastrointestinal symptoms will be quantified using the Gastrointestinal Symptom Rating Scale (GSRS), a validated, self-administered questionnaire consisting of 15 items grouped into five domains: abdominal pain, reflux, indigestion, diarrhea, and constipation.
Each item is rated on a 7-point Likert scale (1 = no discomfort to 7 = very severe discomfort).
Domain scores and total GSRS score will be calculated as the mean of item scores, with higher scores indicating greater symptom severity.
The primary endpoint is the change in total GSRS score from baseline to Week 8.
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Baseline and Week 8 (8 weeks)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OsmaniyeKAU-SBF-CA-04
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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