Effect of Reflexology Massage on Pain and Anxiety.

NCT ID: NCT05428644

Last Updated: 2022-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-10

Study Completion Date

2022-10-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A double-blind randomised controlled clinical trial.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

massage therapy

Intervention Type BEHAVIORAL

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 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.

Group Type PLACEBO_COMPARATOR

massage therapy

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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%)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dokuz Eylul University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gizem Göktuna

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gülşah Gürol Arslan, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate professor

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dokuz Eylül University

Balçova, İzmir, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021/04-24 08.02.2021

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.