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The Power of Hand Reflexology in Ameliorating Anxiety, Pain, and Fatigue Among Patients Undergoing Coronary Angiography

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hand Reflexology
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Artery Disease

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Nursing, Alexandria university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

STUDY GROUP

Group 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain intensity
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."
Fatigue
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.
Anxiety
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.

Secondary Outcome Measures

Full Information

First Posted
May 23, 2023
Last Updated
June 1, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05887362
Brief Title
The Power of Hand Reflexology in Ameliorating Anxiety, Pain, and Fatigue Among Patients Undergoing Coronary Angiography
Official Title
The Power of Hand Reflexology in Ameliorating Anxiety, Pain, and Fatigue Among Patients Undergoing Coronary Angiography
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
November 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STUDY GROUP
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Hand Reflexology
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity
Description
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."
Time Frame
4 months
Title
Fatigue
Description
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.
Time Frame
4 months
Title
Anxiety
Description
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.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of Nursing, Alexandria university
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Power of Hand Reflexology in Ameliorating Anxiety, Pain, and Fatigue Among Patients Undergoing Coronary Angiography

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