Self-Affirmation for Managing Anxiety and Perceived Discomfort in Open-Heart Surgery
NCT ID: NCT05487430
Last Updated: 2022-08-04
Study Results
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Basic Information
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COMPLETED
NA
61 participants
INTERVENTIONAL
2019-07-30
2020-03-20
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention Group
Self-affirmation audio recording included 40 positive sentences in order to increase the sensation of well-being of the patients. Some examples are:
1. Now I have decided to think more positively.
2. I am in control of my thoughts.
3. I am completely relaxed.
4. I am strong, and I am aware of my strength.
5. I can be comfortable and positive in any situation.
6. I love myself as I am and accept myself for who I am.
7. I know very well how to relax.
8. All my muscles relax with every deep breath I take.
9. I leave myself in peace.
10. I am a relaxed, joyful, and happy person.
11. I am calm at all times and in all situations.
12. I know that everything that happens in my life happens for my own good.
13. I am very good at relaxing.
14. My life energy is rising.
15. I am surrounded by positive energy.
In the background of the recording there were sounds of birds crowing and river-like flowing water together for increasing the effect of relaxation.
Positive Self-Affirmation
Each participant of the intervention group was given a set of earphones and an MP3 player which included an audio recording with a background sound of birds crowing and river-like flowing water together with the positive affirmation sentences. The self-affirmation sentences were created by the first author by paying special attention to not using negative predicates and words with negative meanings such as pain, nausea, and discomfort. In the audio recording, the affirmative sentences were verbalized by the first author with a soothing voice. Between each sentence, a pause is given so that the patient can repeat each sentence verbally or internally. The audio recording lasted 5 minutes 40 seconds and the patients were asked to listen to it at least once a day, however, they were encouraged to listen to it as much as they wanted.
Control Group
The participants of the control group only received the conventional care given in the inpatient clinic.
No interventions assigned to this group
Interventions
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Positive Self-Affirmation
Each participant of the intervention group was given a set of earphones and an MP3 player which included an audio recording with a background sound of birds crowing and river-like flowing water together with the positive affirmation sentences. The self-affirmation sentences were created by the first author by paying special attention to not using negative predicates and words with negative meanings such as pain, nausea, and discomfort. In the audio recording, the affirmative sentences were verbalized by the first author with a soothing voice. Between each sentence, a pause is given so that the patient can repeat each sentence verbally or internally. The audio recording lasted 5 minutes 40 seconds and the patients were asked to listen to it at least once a day, however, they were encouraged to listen to it as much as they wanted.
Eligibility Criteria
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Inclusion Criteria
* not having any history of a previous open cardiothoracic surgery
* being over 18 years
* being literate in Turkish.
Exclusion Criteria
* having hearing deficiency
* having an emergency coronary artery bypass surgery
* staying in the cardiac intensive care unit for more than 48-hours
18 Years
ALL
No
Sponsors
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Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery and Research Hospital
UNKNOWN
Trakya University
OTHER
University of Vic - Central University of Catalonia
OTHER
Responsible Party
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Meltem Yildirim
Associated Professor
Principal Investigators
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Meltem Yildirim, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Vic - Central University of Catalonia
Locations
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Mehmet Akif Ersoy Thoracic and Cardiovacular Surgery Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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References
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Other Identifiers
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2019-52
Identifier Type: -
Identifier Source: org_study_id
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