Effect of Reflexology Massage on Pain and Anxiety.

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05428644
• Other study ID #: 2021/04-24 08.02.2021
• Status: Completed
• Phase: N/A
• Start date: February 10, 2022
• Est. completion date: October 10, 2022

Study information

• Verified date: November 2022
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 10, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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%)

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Turkey	Dokuz Eylül University	Balçova	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.