Effect of Foot Massage After Coronary Angıography on Back Paın and Vıtal Sıgns
The Research Was Planned As a Randomized Controlled Experimental Study to Evaluate the Effects of Foot Massage on Back Pain and Vital Signs in Patients Undergoing Coronary Angiography.
1 other identifier
interventional
60
1 country
1
Brief Summary
The aim of the study was to evaluate the effect of foot massage on patients' back pain and vital signs after coronary angiography. It is important for the transfer of nonpharmacological methods to clinical applications
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2024
CompletedStudy Start
First participant enrolled
January 15, 2025
CompletedFirst Posted
Study publicly available on registry
January 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2025
CompletedJanuary 17, 2025
January 1, 2025
6 months
December 18, 2024
January 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Effect of foot massage after coronary angiography on back pain
Visual Analog Scale, The scale was developed by Freyd M. in 2001. VAS, which is a simple, effective, repeatable and minimally instrumented measurement tool, is a one-dimensional scale frequently used in the measurement of subjective parameters. The scale consists of a 10 cm long line drawn vertically or horizontally. At both ends of this line are the two extreme descriptive words of the subjective category (0 = "no pain at all", 10 = worst/unbearable pain"). The patient is asked to mark the appropriate place on this line where the pain intensity will intersect. The distance from the lowest VAS level to the patient's mark is measured with a ruler and the numerical value of the patient's pain intensity is obtained in centimeters(cm) or millimeters (mm).
The scale will be re-applied to patients half an hour, at the 1st hour, at the 4th hour and at the 8th hour after angiography.
Effect of foot massage after coronary angiography on vital signs
Vital Signs Evaluation Form:Pulse(bpm), systolic blood pressure (mmHg), diastolic blood pressure (mmHg) and respiratory rate measurements(breaths/minute) of the patients before and after the procedure will be recorded on the form prepared by the researcher.
The scale will be re-applied to patients half an hour, at the 1st hour, at the 4th hour and at the 8th hour after angiography.
Study Arms (2)
foot massage
EXPERIMENTALPain and vital signs will be assessed for patients in the intervention group half an hour after they have stabilized after angiography. Foot massage will be applied at 1 hour after angiography. 8 minutes of foot massage will be applied to each foot (16 minutes in total for both feet). Vital signs and VAS will be assessed again immediately after the application, at 4 hours and at 8 hours.
control group
NO INTERVENTIONNo application will be made to the patients in the control group, and only the routine post-angiography care services of the service will be provided. Pain and vital signs assessment will be repeated half an hour, 1 hour, 4 hours and 8 hours after the patients leave the angiography.
Interventions
The characteristics of Massage Manipulations are an important feature in planning. Since the purpose of the massage is to rest, calm and relax, Effleurage (Stroke), Petrisage (Kneading) and Friction (Circular Rubbing) techniques that support circulation and have a loosening effect on the tissues have been chosen.A massage will be given to both feet for a total of 16 minutes, 8 minutes for each foot.The person receiving the massage will be lying down comfortably in a supine position, supported by pillows under the head and lower legs.Foot massage will be applied once to patients in the supine position at the first hour after their admission to the coronary intensive care unit following transfemoral angiography.
Eligibility Criteria
You may qualify if:
- Literate
- Over 18 years of age,
- Transfemoral CAG,
- No vision or hearing problems,
- Dorsal pedal and posterior tibial pulses are normal,
- No back pain in the last week before CAG,
You may not qualify if:
- No physiological or hemodynamic instability during and after CAG,
- Sensory disorders that impair the perception of back pain (paraplegia)
- Active bleeding at the site of cardiac dysrhythmia or catheter insertion,
- Known hemorrhagic disorders,
- History of spinal surgery or herniated disc in the lower back,
- Inflammation or infection in the leg or sole,
- Serious health problems in the feet,
- Not using opioid agents, tranquilizers or anesthetics before, during and 4 hours after CAG
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ayşenur kahvecilead
Study Sites (1)
Çukurova Üniversitesi
Adana, Adana, 01, Turkey (Türkiye)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- PhD student and nurse
Study Record Dates
First Submitted
December 18, 2024
First Posted
January 17, 2025
Study Start
January 15, 2025
Primary Completion
June 30, 2025
Study Completion
October 15, 2025
Last Updated
January 17, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ICF
- Time Frame
- Once published, the data is available indefinitely.
- Access Criteria
- Data can be shared publicly.
Pre- and post- implementation results of intervention and control group scales (statistical analysis). Participants' descriptive characteristics and participant consent form.