NCT05887362

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
Last Updated

June 2, 2023

Status Verified

June 1, 2023

Enrollment Period

4 months

First QC Date

May 23, 2023

Last Update Submit

June 1, 2023

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (3)

  • 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."

    4 months

  • 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.

    4 months

  • 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.

    4 months

Study Arms (2)

STUDY GROUP

EXPERIMENTAL

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.

Behavioral: Hand Reflexology

Group 2

NO INTERVENTION

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.

Interventions

Hand ReflexologyBEHAVIORAL

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.

STUDY GROUP

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with severe mental problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing, Alexandria university

Alexandria, Egypt

Location

Related Publications (1)

  • Ali EA, Awad WHA, Khedr MA, Rabie EAEGA. Effect of hand reflexology in ameliorating anxiety, pain, and fatigue among patients undergoing coronary angiography. BMC Complement Med Ther. 2023 Nov 24;23(1):425. doi: 10.1186/s12906-023-04256-6.

    PMID: 38001461DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 23, 2023

First Posted

June 2, 2023

Study Start

July 1, 2022

Primary Completion

November 1, 2022

Study Completion

November 15, 2022

Last Updated

June 2, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)