The Effect Of Reflexology On Pain, Anxiety And Comfort Level

NCT06007716 | Unknown

• 1 other identifier: HU-SM-KM-01
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myocardial Infarction; Angina Pectoris

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• State-Trait Anxiety Inventory

  2 days

Other Outcomes (1)

• General Comfort Scale Short Form

  2 days

Study Arms (2)

Experimental group

ACTIVE COMPARATOR

it was planned to apply reflexology massage once a day for each patient for 2 consecutive days, in total 2 sessions.

Other: reflexology massage

placebo group

PLACEBO COMPARATOR

placebo massage was applied once a day for each patient for 2 consecutive days, for a total of 2 sessions.

Other: Placebo massage

Interventions

reflexology massage OTHER

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.

Experimental group

Placebo massage OTHER

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.

placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hakkari Universitesi: lead

Study Sites (1)

Van Regional Training and Research Hospital

Van, 65100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myocardial Infarction; Angina Pectoris

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Kamber SÜMER

  PhD student

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were informed about the study after obtaining an informed consent form. It was noted that the participants had not received reflexology or classical massage before.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: consists of experimental and placebo groups.

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 23, 2023
• Study Start: July 1, 2021
• Primary Completion: February 27, 2022
• Study Completion: September 30, 2023
• Last Updated: August 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)