The Effect Of Reflexology On Pain, Anxiety And Comfort Level

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Myocardial Infarction, Angina Pectoris

Intervention / Treatment
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* Other: reflexology massage
* Other: Placebo massage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: consists of experimental and placebo groups.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental group<br>it was planned to apply reflexology massage once a day for each patient for 2 consecutive days, in total 2 sessions. | Other: reflexology massage<br>* 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.<br>|
| Placebo Comparator: placebo group<br>placebo massage was applied once a day for each patient for 2 consecutive days, for a total of 2 sessions. | Other: Placebo massage<br>* 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.<br>|

What is the study measuring?
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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 |