Effect of Reflexology Massage on Pain and Anxiety.

November 14, 2022 updated by: Gizem Göktuna, Dokuz Eylul University

The Effect of Massage on Patients Undergoing Coronary Artery Bypass Graft Surgery

Aim: The aim of this study is to examine the effects of reflexology hand massage group and placebo group on pain and anxiety in patients undergoing coronary artery bypass graft surgery.

Method: Individuals who have undergone coronary artery bypass graft surgery in accordance with the sampling inclusion criteria will be allocated to the reflexology and placebo groups by block randomization using the randomization method. After the groups are determined, the patients in the reflexology hand massage group and placebo group will be asked to fill in the Socio-Demographic Information Form, the State Anxiety Scale and the Visual Analog Scale will be taken.

In addition to the standard nursing care of the hospital, individuals in the reflexology group and placebo group will be massaged for 10 minutes, a total of 20 minutes, after the extubation procedure. Individuals in the reflexology group and placebo group will be followed up before the massage (0. minute) and after the massage at the 5th, 30th and 60th minutes, and the data will be recorded.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pain and anxiety are common postoperative problems that impair recovery and quality of life in patients undergoing coronary artery bypass graft (CABG) surgery. These problems cause changes in physiological parameters, prolonged recovery, sleep problems and a decrease in quality of life in patients. Hand reflexology, which is among the non-pharmacological methods, is an effective intervention that nurses can apply independently in the management of pain and anxiety.Therefore, this study aimed to examine the effect of reflexology on pain and anxiety.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • İzmir
      • Balçova, İzmir, Turkey, 35340
        • Dokuz Eylul University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • To be over 18 years of age,
  • To know Turkish and to agree to participate in the research
  • No previous open heart surgery
  • Non-urgent planned bypass surgery
  • Without any intra-aortic balloon pump or pacemaker
  • Not taking inotropic drugs
  • Patients who have no problem to apply massage; Those who do not have any skin lesions, burns
  • Extubated
  • Not taking analgesics

Exclusion Criteria:

  • Mitral valve repair or replacement during CABG surgery
  • Those who have any skin lesions, burns, open wounds, muscle and bone-related pathological disease, phlebitis
  • Not disconnected from mechanical ventilation
  • Having a risk factor for complications (e.g: ejection fraction < 35%)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: reflexology hand massage group
In addition to the standard nursing care of the hospital, individuals in the reflexology hand massage will be given a 10-minute massage for both hands, a total of 20 minutes, after the extubation procedure.
Behavioral: massage therapy
In addition to the standard nursing care of the hospital, individuals in the reflexology hand massage and placebo hand massage group will be given a 10-minute massage for both hands, a total of 20 minutes, after the extubation procedure.
Placebo Comparator: placebo hand massage group
In addition to the standard nursing care of the hospital, individuals in the placebo hand massage group will be given a 10-minute massage for both hands, a total of 20 minutes, after the extubation procedure.
Behavioral: massage therapy
In addition to the standard nursing care of the hospital, individuals in the reflexology hand massage and placebo hand massage group will be given a 10-minute massage for both hands, a total of 20 minutes, after the extubation procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain scores of reflexology hand massage and placebo hand massage group
Time Frame: Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up before the massage.
Comparison of pain scores between reflexology hand massage and placebo hand massage groups. The patients' pain score data were collected by the Visual Analog Scale. It is a 10-point scale. Higher points show a higher level of pain.
Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up before the massage.
pain scores of reflexology hand massage and placebo hand massage group
Time Frame: Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up 5th minute after the massage.
Comparison of pain scores between reflexology hand massage and placebo hand massage groups. The patients' pain score data were collected by the Visual Analog Scale. It is a 10-point scale. Higher points show a higher level of pain.
Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up 5th minute after the massage.
pain scores of reflexology hand massage and placebo hand massage group
Time Frame: Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up 30th minute after the massage.
Comparison of pain scores between reflexology hand massage and placebo hand massage groups. The patients' pain score data were collected by the Visual Analog Scale. It is a 10-point scale. Higher points show a higher level of pain.
Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up 30th minute after the massage.
pain scores of reflexology hand massage and placebo hand massage group
Time Frame: Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up 60th minute after the massage.
Comparison of pain scores between reflexology hand massage and placebo hand massage groups. The patients' pain score data were collected by the Visual Analog Scale. It is a 10-point scale. Higher points show a higher level of pain.
Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up 60th minute after the massage.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anxiety scores of reflexology hand massage and placebo hand massage group
Time Frame: Individuals in the reflexology hand massage and placebo hand massage groups will be followed up before the massage.
Comparison of anxiety scores between reflexology hand massage and placebo hand massage groups. The patients' anxiety score data were collected by the State Anxiety Inventory. It is a 20-item scale. The scores in the inventory range from 20 to 80. Higher points show a higher level of anxiety.
Individuals in the reflexology hand massage and placebo hand massage groups will be followed up before the massage.
anxiety scores of reflexology hand massage and placebo hand massage group
Time Frame: Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up 60th minute after the massage.
Comparison of anxiety scores between reflexology hand massage and placebo hand massage groups. The patients' anxiety score data were collected by the State Anxiety Inventory. It is a 20-item scale. The scores in the inventory range from 20 to 80. Higher points show a higher level of anxiety.
Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up 60th minute after the massage.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dokuz Eylul University

Investigators

  • Principal Investigator: Gülşah Gürol Arslan, PhD, Associate professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2022

Primary Completion (Actual)

September 15, 2022

Study Completion (Actual)

October 10, 2022

Study Registration Dates

First Submitted

March 23, 2022

First Submitted That Met QC Criteria

June 20, 2022

First Posted (Actual)

June 23, 2022

Study Record Updates

Last Update Posted (Actual)

November 15, 2022

Last Update Submitted That Met QC Criteria

November 14, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/04-24 08.02.2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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