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Effect of Reflexology Massage on Pain and Anxiety.

Primary Purpose

Pain, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
massage therapy
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain focused on measuring hand reflexology, nursing care, pain management

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%)

Sites / Locations

  • Dokuz Eylül University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

reflexology hand massage group

placebo hand massage group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
March 23, 2022
Last Updated
November 14, 2022
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT05428644
Brief Title
Effect of Reflexology Massage on Pain and Anxiety.
Official Title
The Effect of Massage on Patients Undergoing Coronary Artery Bypass Graft Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 10, 2022 (Actual)
Primary Completion Date
September 15, 2022 (Actual)
Study Completion Date
October 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety
Keywords
hand reflexology, nursing care, pain management

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A double-blind randomised controlled clinical trial.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
reflexology hand massage group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
placebo hand massage group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
massage therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
pain scores of reflexology hand massage and placebo hand massage group
Description
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.
Time Frame
Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up before the massage.
Title
pain scores of reflexology hand massage and placebo hand massage group
Description
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.
Time Frame
Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up 5th minute after the massage.
Title
pain scores of reflexology hand massage and placebo hand massage group
Description
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.
Time Frame
Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up 30th minute after the massage.
Title
pain scores of reflexology hand massage and placebo hand massage group
Description
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.
Time Frame
Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up 60th minute after the massage.
Secondary Outcome Measure Information:
Title
anxiety scores of reflexology hand massage and placebo hand massage group
Description
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.
Time Frame
Individuals in the reflexology hand massage and placebo hand massage groups will be followed up before the massage.
Title
anxiety scores of reflexology hand massage and placebo hand massage group
Description
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.
Time Frame
Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up 60th minute after the massage.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülşah Gürol Arslan, PhD
Organizational Affiliation
Associate professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dokuz Eylül University
City
Balçova
State/Province
İzmir
ZIP/Postal Code
35340
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Reflexology Massage on Pain and Anxiety.

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