Effect of Reflexology Massage on Pain and Anxiety.

Sponsor
Dokuz Eylul University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05428644
Collaborator
(none)
50
1
2
5.7
8.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: massage therapy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A double-blind randomised controlled clinical trial.A double-blind randomised controlled clinical trial.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Massage on Patients Undergoing Coronary Artery Bypass Graft Surgery
Actual Study Start Date :
Feb 10, 2022
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. pain scores of reflexology hand massage and placebo hand massage group [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.

  2. pain scores of reflexology hand massage and placebo hand massage group [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.

  3. pain scores of reflexology hand massage and placebo hand massage group [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.

  4. pain scores of reflexology hand massage and placebo hand massage group [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.

Secondary Outcome Measures

  1. anxiety scores of reflexology hand massage and placebo hand massage group [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.

  2. anxiety scores of reflexology hand massage and placebo hand massage group [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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%)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dokuz Eylül University Balçova İzmir Turkey 35340

Sponsors and Collaborators

  • Dokuz Eylul University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gizem Göktuna, Principal Investigator, Dokuz Eylul University
ClinicalTrials.gov Identifier:
NCT05428644
Other Study ID Numbers:
  • 2021/04-24 08.02.2021
First Posted:
Jun 23, 2022
Last Update Posted:
Jul 27, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gizem Göktuna, Principal Investigator, Dokuz Eylul University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2022