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The Effect Of Reflexology On Pain, Anxiety And Comfort Level

Primary Purpose

Myocardial Infarction, Angina Pectoris

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
reflexology massage
Placebo massage
Sponsored by
Hakkari Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Myocardial Infarction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Van Regional Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Experimental group

placebo group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 17, 2023
Last Updated
August 17, 2023
Sponsor
Hakkari Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT06007716
Brief Title
The Effect Of Reflexology On Pain, Anxiety And Comfort Level
Official Title
The Effect Of Reflexology Massage On Pain, Anxiety And Comfort Level In Patients Undergoing Percutaneous Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
February 27, 2022 (Actual)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hakkari Universitesi

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Angina Pectoris

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
consists of experimental and placebo groups.
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Active Comparator
Arm Description
it was planned to apply reflexology massage once a day for each patient for 2 consecutive days, in total 2 sessions.
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
placebo massage was applied once a day for each patient for 2 consecutive days, for a total of 2 sessions.
Intervention Type
Other
Intervention Name(s)
reflexology massage
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo massage
Intervention Description
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.
Primary Outcome Measure Information:
Title
The McGill Pain Scale Short Form-2
Description
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.
Time Frame
2 days
Secondary Outcome Measure Information:
Title
State-Trait Anxiety Inventory
Description
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.
Time Frame
2 days
Other Pre-specified Outcome Measures:
Title
General Comfort Scale Short Form
Description
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).
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamber SÜMER
Organizational Affiliation
PhD student
Official's Role
Principal Investigator
Facility Information:
Facility Name
Van Regional Training and Research Hospital
City
Van
ZIP/Postal Code
65100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect Of Reflexology On Pain, Anxiety And Comfort Level

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