- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05887362
The Power of Hand Reflexology in Ameliorating Anxiety, Pain, and Fatigue Among Patients Undergoing Coronary Angiography
June 1, 2023 updated by: Mahmoud Khedr, Alexandria University
Reflexology influences pain perception and pain-impulse transmission by releasing endorphins (12).
Patients with a variety of medical illnesses can benefit from hand reflexology by lessening their physical and emotional discomfort (13, 14).
Therefore, this study was done to investigate the power of hand reflexology in ameliorating anxiety, pain, and fatigue among patients undergoing coronary angiography
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Alexandria, Egypt
- Faculty of Nursing, Alexandria University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Criteria:
Inclusion Criteria:
- Patients between the ages of 20 and 60 who were scheduled for non-emergency CA, Absence of any hands' sensory motor disorders, or upper limb vascular injuries.
- No abnormalities such as amputations, burns, skin lesions, and intervertebral disc herniation.
- No history of mental illnesses.
Exclusion Criteria:
Patients with severe mental problems
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: STUDY GROUP
Each patient in the study group received 8 sessions of hand reflexology after CA in a room separating them from the patients in the control group.Using pleasant odourless almond oil to lubricate the patients' hands, the researcher used Ingham's approach to hand reflexology for 10 minutes, applying pressure for 5 minutes on the right hand and then the left.
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Reflexology is a well-known, safe, and noninvasive alternative medicine technique.
It alludes to a treatment that is applied to particular areas of the hands and feet.
The compression on the hands or feet serves as a sensor linked to particular body areas.
These sensors are activated by the reflexology technique to improve blood flow, energize, relax, and maintain homeostasis.
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No Intervention: Group 2
The control group was selected first and received the routine care delivered by the hospital, such as assessment of vital signs, supine position, complete bed rest, and hygienic care.
They didn't receive the hand reflexology intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: 4 months
|
It is a 10 cm horizontal line with two ends; the left end typically denotes "no pain," while the right end typically denotes "worst possible pain."
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4 months
|
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Fatigue
Time Frame: 4 months
|
The Rhoten Fatigue Scale (RFS) is a subjective rating scale developed by (16) to measure a patient's fatigue level.
It comprises a 10-centimeter line with extremely positive and negative statements at either end.
|
4 months
|
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Anxiety
Time Frame: 4 months
|
The Beck Anxiety Inventory (BAI) was developed in 1988 by (17) to assess the severity of anxiety symptoms.
The Likert scale for the 21 items that comprise the BAI ranges from 0 to 3. The overall score is between 0 and 63.
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2022
Primary Completion (Actual)
November 1, 2022
Study Completion (Actual)
November 15, 2022
Study Registration Dates
First Submitted
May 23, 2023
First Submitted That Met QC Criteria
June 1, 2023
First Posted (Estimated)
June 2, 2023
Study Record Updates
Last Update Posted (Estimated)
June 2, 2023
Last Update Submitted That Met QC Criteria
June 1, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022935
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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