NCT06779955

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Completed
28 days until next milestone

Study Start

First participant enrolled

January 15, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

December 18, 2024

Last Update Submit

January 15, 2025

Conditions

Keywords

CADNURSİNGayak masajı

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

EXPERIMENTAL

Pain 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.

Behavioral: foot massage application

control group

NO INTERVENTION

No 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.

foot massage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Çukurova Üniversitesi

Adana, Adana, 01, Turkey (Türkiye)

Location

Central Study Contacts

Ayşenur K KAHVECİ

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Simple randomization was used in the study.By computer randomization ,patients were divided into intervention and control groups.
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

Pre- and post- implementation results of intervention and control group scales (statistical analysis). Participants' descriptive characteristics and participant consent form.

Shared Documents
ICF
Time Frame
Once published, the data is available indefinitely.
Access Criteria
Data can be shared publicly.
More information

Locations