Effect of Reflexology Massage on Pain and Anxiety.

NCT05428644 | Completed

• 1 other identifier: 2021/04-24 08.02.2021
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Anxiety

Keywords

hand reflexology; nursing care; pain management

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  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

  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

  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 Outcomes (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 followed up before the massage.

• 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.

Study Arms (2)

reflexology hand massage group

ACTIVE COMPARATOR

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

placebo hand massage group

PLACEBO COMPARATOR

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

Interventions

massage therapy 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; reflexology hand massage group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%)

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylül University

Balçova, İzmir, 35340, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders; Agnosia

Interventions

Massage

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Gülşah Gürol Arslan, PhD

  Associate professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A double-blind randomised controlled clinical trial.

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: June 23, 2022
• Study Start: February 10, 2022
• Primary Completion: September 15, 2022
• Study Completion: October 10, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)