Clinical trial NCT05428644: Effect of Reflexology Massage on Pain and Anxiety.
Official title: The Effect of Massage on Patients Undergoing Coronary Artery Bypass Graft Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Keywords: hand reflexology
nursing care
pain management
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2022-06-23
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A double-blind randomised controlled clinical trial.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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%)

Primary outcomes:
measure: pain scores of reflexology hand massage and placebo hand massage group
timeFrame: Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up before the massage.
measure: pain scores of reflexology hand massage and placebo hand massage group
timeFrame: Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up 5th minute after the massage.
measure: pain scores of reflexology hand massage and placebo hand massage group
timeFrame: Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up 30th minute after the massage.
measure: pain scores of reflexology hand massage and placebo hand massage group
timeFrame: Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up 60th minute after the massage.
Secondary outcomes:
measure: anxiety scores of reflexology hand massage and placebo hand massage group
timeFrame: Individuals in the reflexology hand massage and placebo hand massage groups will be followed up before the massage.
measure: anxiety scores of reflexology hand massage and placebo hand massage group
timeFrame: Individuals in the reflexology hand massage and placebo hand massage groups will be monitored up 60th minute after the massage.
Other outcomes:
Locations:
city: Balçova
country: Turkey
facility: Dokuz Eylül University
state: İzmir
Study officials:
affiliation: Associate professor
name: Gülşah Gürol Arslan, PhD
role: PRINCIPAL_INVESTIGATOR
References: