Effect of Reflexology Massage on Pain and Anxiety.

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Anxiety

Intervention / Treatment
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* Behavioral: massage therapy


Participation Criteria
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Eligibility Criteria
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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%)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A double-blind randomised controlled clinical trial.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: reflexology hand massage group<br>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<br>* 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.<br>|
| Placebo Comparator: placebo hand massage group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. | Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up 60th minute after the massage. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hand reflexology, nursing care, pain management