Clinical trial NCT06007716: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myocardial Infarction
Angina Pectoris
Lead sponsor: Hakkari Universitesi
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: consists of experimental and placebo groups.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: The McGill Pain Scale Short Form-2
timeFrame: 2 days
Secondary outcomes:
measure: State-Trait Anxiety Inventory
timeFrame: 2 days
Other outcomes:
measure: General Comfort Scale Short Form
timeFrame: 2 days
Locations:
city: Van
country: Turkey
facility: Van Regional Training and Research Hospital
Study officials:
affiliation: PhD student
name: Kamber SÜMER
role: PRINCIPAL_INVESTIGATOR
References: