Clinical trial NCT05487430: Self-Affirmation for Managing Anxiety and Perceived Discomfort in Open-Heart Surgery
Official title: The Effect of Self-Affirmation on Anxiety and Perceived Discomfort in Patients Who Underwent Open-Heart Surgery. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Cardiac Disease
Keywords: anxiety
discomfort
open-heart surgery
self-affirmation
randomized controlled trial
Lead sponsor: University of Vic - Central University of Catalonia
Sponsor class: OTHER
Collaborators: name: Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery and Research Hospital
name: Trakya University
First posted: 2022-08-04
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised assignation of participants into two study groups: Intervention and Control.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study adopted a randomized controlled pretest-posttest follow-up research design. The study was conducted at a public training and research hospital (Istanbul, Turkey) specialized in thoracic and cardiovascular surgery. The sample consisted of 61 patients randomized into two groups: intervention (n=34) and control (n=27). The participants of the intervention group listened to a self-affirmation audio recording for three days after surgery. Anxiety levels and perceived discomfort regarding pain, dyspnoea, palpitations, fatigue and nausea were measured daily. The study's main question is How do self-affirmation affect postoperative anxiety and perceived discomfort (regarding pain, dyspnoea, palpitations, fatigue and nausea) in patients who undergo open-heart surgery? In accordance with this question, the hypotheses was that repetitive positive self-affirmations decrease both anxiety and perceived discomfort in patients who underwent open-heart surgery.

Detailed description: This study adopted a randomized controlled pretest-posttest follow-up research design in accordance with CONSORT guidelines with 2 study groups (intervention and control).

The study was conducted among the patients who underwent open-heart surgery in the in-patient clinics of a public hospital (Istanbul, Turkey). Following the surgical intervention, all patients were admitted to the cardiac intensive care unit (CICU) for close postoperative follow-up. According to the hospital protocol, the minimum duration for a CICU stay is 2 days after surgery in patients that are hemodynamically stabilized. On their 3rd postoperative day, they are discharged from CICU to be admitted to the in-patient clinic and; in this study, their first day in the clinic was considered as the adaptation and resting period, so that the sampling process was started on the 4th postoperative day.

Eighty-five patients were assessed for eligibility. Five patients excluded from the study before randomization. Following the randomization, 12 patients were excluded during the initial allocation and then 7 more patients were excluded during the follow-up. The final study sample consisted of 61 patients who underwent CABS; 34 in the intervention group and 27 in the control group.

The baseline data (pre-test) was obtained on the fourth postoperative day considering the fact that the patients were comfortably adapted to the in-patient clinic and were more open to collaborate in the study. Additionally, preoperative anxiety weren't considered as a baseline evaluation because it is known that during the preoperative period the sources of anxiety are mainly related to uncertainties and fear of death, however during the postoperative period the patients are more likely to be concerned about their need to be protected, in other words, their vulnerability and fragility.

Each patient was followed up for 3 days. The data collection process was lasted 4 months, between the 20th of November of 2019 and the 20th of March of 2020.

In this study, intention-to-treat analysis was not used as all the participants were asked to listen to the self-affirmation recording at least once a day, because daily repetition is the key element when affirming positive sentences in order to mobilize the inner sources of the individual. Therefore, only per-protocol analysis where all participants strictly adhered to the study protocol was conducted.

The data were analysed by using the Statistical Package for the Social Sciences (IBM, SPSS, 21.0) at a significance level of 0.05. In the descriptive analysis, mean was used for the numerical data, and frequency for the categorical data. The homogeneity between the study groups regarding the participants' descriptive characteristics was tested with the Chi-Square test. Repeated measures analysis of variance (ANOVA) was used to identify the differences between the study groups, meanwhile within-group comparisons were done by the Independent Sample t-Test. The power analyses conducted with G\*Power indicated that this study had high power (1 - β = 0.93) with the effect size of d=0.91 (α=0,05).

Eligibility criteria: Inclusion Criteria:

* undergoing coronary artery bypass surgery for the first time,
* not having any history of a previous open cardiothoracic surgery
* being over 18 years
* being literate in Turkish.

Exclusion Criteria:

* having a diagnosed anxiety disorder
* having hearing deficiency
* having an emergency coronary artery bypass surgery
* staying in the cardiac intensive care unit for more than 48-hours

Primary outcomes:
measure: Change in the level of state anxiety on 3 consecutive days
timeFrame: During 3 days, one measurement per day
Secondary outcomes:
measure: Change in the perceived level of pain on 3 consecutive days, measured by 0 to 10 numeric rating scale
timeFrame: During 3 days, one measurement per day
measure: Change in the perceived level of dyspnoea on 3 consecutive days, measured by 0 to 10 numeric rating scale
timeFrame: During 3 days, one measurement per day
measure: Change in the perceived level of palpitations on 3 consecutive days, measured by 0 to 10 numeric rating scale
timeFrame: During 3 days, one measurement per day
measure: Change in the perceived level of fatigue on 3 consecutive days, measured by 0 to 10 numeric rating scale
timeFrame: During 3 days, one measurement per day
measure: Change in the perceived level of nausea on 3 consecutive days, measured by 0 to 10 numeric rating scale
timeFrame: During 3 days, one measurement per day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Mehmet Akif Ersoy Thoracic and Cardiovacular Surgery Training and Research Hospital
Study officials:
affiliation: University of Vic - Central University of Catalonia
name: Meltem Yildirim, PhD
role: PRINCIPAL_INVESTIGATOR
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