Clincosm LogoSign in Get a demo

Self-Affirmation for Managing Anxiety and Perceived Discomfort in Open-Heart Surgery

Sponsor
University of Vic - Central University of Catalonia (Other)
Overall Status
Completed
CT.gov ID
NCT05487430
Collaborator
Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery and Research Hospital (Other), Trakya University (Other)
61
Enrollment
1
Location
2
Arms
7.7
Actual Duration (Months)
7.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Positive Self-Affirmation
 N/A

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
61 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomised assignation of participants into two study groups: Intervention and Control.Randomised assignation of participants into two study groups: Intervention and Control.
Masking:
None (Open Label)
Masking Description:
Blinding the intervention group from the clinical staff and from the researchers was not possible due to the fact that the patients were listening to the affirmation recordings.
Primary Purpose:
Supportive Care
Official Title:
The Effect of Self-Affirmation on Anxiety and Perceived Discomfort in Patients Who Underwent Open-Heart Surgery. A Randomized Controlled Trial
Actual Study Start Date :
Jul 30, 2019
Actual Primary Completion Date :
Mar 20, 2020
Actual Study Completion Date :
Mar 20, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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: Now I have decided to think more positively. I am in control of my thoughts. I am completely relaxed. I am strong, and I am aware of my strength. I can be comfortable and positive in any situation. I love myself as I am and accept myself for who I am. I know very well how to relax. All my muscles relax with every deep breath I take. I leave myself in peace. I am a relaxed, joyful, and happy person. I am calm at all times and in all situations. I know that everything that happens in my life happens for my own good. I am very good at relaxing. My life energy is rising. 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.

Behavioral: 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.
No Intervention: Control Group

The participants of the control group only received the conventional care given in the inpatient clinic.

Outcome Measures

Primary Outcome Measures

  1. Change in the level of state anxiety on 3 consecutive days [During 3 days, one measurement per day]

    The primary outcome of the study was the level of state anxiety during the postoperative stay in the in-patient clinic. The State Trait Anxiety Inventory (STAI) was used to measure the level of anxiety. It is a 40 item, 4-point Likert scale ranging from 1 (not at all) to 4 (very much so) and consisting of two sub-dimensions; state anxiety and trait anxiety, 20 items each. The scale was developed by Spielberger et al. in 1970 and adapted to Turkish by Öner and LeCompte in 1983. The total score ranges from 20 to 80 where higher scores indicate higher levels of anxiety. For the subsequent measurements of anxiety, only the state dimension of the STAI was used.

Secondary Outcome Measures

  1. Change in the perceived level of pain on 3 consecutive days, measured by 0 to 10 numeric rating scale [During 3 days, one measurement per day]

    Patients' level of perceived discomfort regarding pain was measured by a Numeric Rating Scale (NRS) of 0 to 10 where higher scores indicate more pain.

  2. Change in the perceived level of dyspnoea on 3 consecutive days, measured by 0 to 10 numeric rating scale [During 3 days, one measurement per day]

    Patients' level of perceived discomfort regarding dyspnoea was measured by a Numeric Rating Scale (NRS) of 0 to 10 where higher scores indicate more dyspnoea.

  3. Change in the perceived level of palpitations on 3 consecutive days, measured by 0 to 10 numeric rating scale [During 3 days, one measurement per day]

    Patients' level of perceived discomfort regarding palpitations was measured by a Numeric Rating Scale (NRS) of 0 to 10 where higher scores indicate more palpitations.

  4. Change in the perceived level of fatigue on 3 consecutive days, measured by 0 to 10 numeric rating scale [During 3 days, one measurement per day]

    Patients' level of perceived discomfort regarding fatigue was measured by a Numeric Rating Scale (NRS) of 0 to 10 where higher scores indicate more fatigue.

  5. Change in the perceived level of nausea on 3 consecutive days, measured by 0 to 10 numeric rating scale [During 3 days, one measurement per day]

    Patients' level of perceived discomfort regarding nausea was measured by a Numeric Rating Scale (NRS) of 0 to 10 where higher scores indicate more nausea.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mehmet Akif Ersoy Thoracic and Cardiovacular Surgery Training and Research Hospital Istanbul Turkey 34290

Sponsors and Collaborators

  • University of Vic - Central University of Catalonia
  • Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery and Research Hospital
  • Trakya University

Investigators

  • Principal Investigator: Meltem Yildirim, PhD, University of Vic - Central University of Catalonia

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Meltem Yildirim, Associated Professor, University of Vic - Central University of Catalonia
ClinicalTrials.gov Identifier:
NCT05487430
Other Study ID Numbers:
  • 2019-52
First Posted:
Aug 4, 2022
Last Update Posted:
Aug 4, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Meltem Yildirim, Associated Professor, University of Vic - Central University of Catalonia
anxiety
discomfort
open-heart surgery
self-affirmation
randomized controlled trial
Additional relevant MeSH terms:
Heart Diseases

Study Results

No Results Posted as of Aug 4, 2022