The Effect Of Reflexology On Pain, Anxiety And Comfort Level

The Effect Of Reflexology Massage On Pain, Anxiety And Comfort Level In Patients Undergoing Percutaneous Coronary Intervention

This study was performed as a randomized controlled a study with a pre test-post test design, aimed to determine affect of reflexology masagge to the pain, anxiety and comfort level on the patients that are percutaneous coronary intervention.

Study Overview

• Status: Active, not recruiting
• Conditions: Myocardial Infarction; Angina Pectoris
• Intervention / Treatment: Other: reflexology massage; Other: Placebo massage

Detailed Description

A total of 74 patients, 37 in the experimental group and 37 in the placebo group, who met the criteria for inclusion in the study, constituted the sample of the study. Research data were collected with "Structured Patient Information Form", "Vital Signs Form", "State Anxiety Scale", "Visual Comparison Scale", "McGill Pain Scale Short Form" and "General Comfort Scale Short Form". Appropriate statistical methods were used in the analysis of the data.

Reflexology massage is a well tolerated, inexpensive, applicable and safe non-pharmacological method. The fact that nurses are educated and experienced about reflexology massage is of great importance for integrating reflexology massage into clinical settings.

If the results of this study are significant, it will be concluded that reflexology massage is effective in the management of pain and anxiety and increasing the comfort level in patients undergoing PCI. It will be recommended that reflexology massage be used in clinics to reduce pain, anxiety and increase comfort level in individuals undergoing PCI, and to include it in patient education. No study has been found in the national literature evaluating the effectiveness of reflexology massage in the management of PCI-related pain, anxiety and comfort. It is thought that this study will fill an important gap in the literature. The aim of this study, carried out in this context, is to reveal the effect of reflexology massage on pain, anxiety and comfort level in patients undergoing PCI.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Van, Turkey, 65100
    • Van Regional Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Over 18 years old,
• Literate, Diagnosed with PCI-related pain,
• Pain score of 4 out of 10 according to Visual Comparison Scale (VAS) after PCI.

Exclusion Criteria:

• Presence of a pacemaker,
• Having a diagnosis of diabetic foot,
• Presence of vision, hearing, cognitive ability impairment or psychosis,
• Being pregnant,
• Presence of disc herniation,
• Any contagious skin disease (shingles, fungus, etc.), open lesion/wound on the lower extremities, scar tissue, fracture, dislocation, amputation, edema, hematoma, thrombophlebitis, inflammatory and degenerative joint disease,
• Having applied reflexology massage in the last month

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Experimental group; it was planned to apply reflexology massage once a day for each patient for 2 consecutive days, in total 2 sessions.	Other: reflexology massage; 5 minutes of classic message on the left foot, 15 minutes of reflexology message, and 5 minutes of classic message on the right foot, 15 minutes of reflexology message, a total of 40 minutes of massage. 30 minutes after the massage, evaluation was recorded with the Vital Signs Registration Form, McGill Pain Scale Short Form, State Anxiety Inventory, General Comfort Scale Short Form, and Fatigue and Quality Sleep Visual Comparison Scale. Thus, reflexology massage is performed once a day for each patient for 2 consecutive days, for a total of 2 sessions.
Placebo Comparator: placebo group; placebo massage was applied once a day for each patient for 2 consecutive days, for a total of 2 sessions.	Other: Placebo massage; Placebo reflexology massage was applied to each foot for 20 minutes, for a total of 40 minutes.30 minutes after the massage, evaluation was recorded with the Vital Signs Registration Form, McGill Pain Scale Short Form, State Anxiety Inventory, General Comfort Scale Short Form, and Fatigue and Quality Sleep Visual Comparison Scale. Thus, Placebo massage is performed once a day for each patient for 2 consecutive days, for a total of 2 sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The McGill Pain Scale Short Form-2	The McGill Pain Scale Short Form, developed by Melzack in 1987, provides information about the sensory characteristics, severity and effect of pain. The validity and reliability study in Turkey was developed by Yakut et al. in 2007. McGill Pain Scale Short Form-2 (MAS-SF-2) was developed in 2010 by revising the McGill Pain Scale Short Form by Bicici and Günes.	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State-Trait Anxiety Inventory	It was developed by Spielberger et al. in 1970 and validated and reliable in Turkish society by Öner and Le Compte (1977). The State-Trait Anxiety Inventory consists of two different parts and includes a total of 40 items, 20 of which are each.	2 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Comfort Scale Short Form	General Comfort Scale Short Form GQS-SF was developed by Kolcaba in 2006. Validity and reliability were established by Saritas et al. in 2018. It includes the sub-dimensions of comfort, relief (9 items), relaxation (9 items), and overcoming problems (10 items).	2 days

Collaborators and Investigators

• Sponsor: Hakkari Universitesi
• Investigators: Principal Investigator: Kamber SÜMER, PhD student

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): February 27, 2022
• Study Completion (Estimated): September 30, 2023

Study Registration Dates

• First Submitted: August 17, 2023
• First Submitted That Met QC Criteria: August 17, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Myocardial Infarction; Infarction; Angina Pectoris
• Other Study ID Numbers: HU-SM-KM-01

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