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NCT Number: NCT05428644

Effect of Reflexology Massage on Pain and Anxiety.

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.

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Key information

Conditions

Pain Agnosia Anxiety Anxiety Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylül University

Balçova, İzmir, 35340, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 23, 2022
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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