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

NCT05487430 | Completed

• 1 other identifier: 2019-52
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Cardiac Disease

Keywords

anxiety; discomfort; open-heart surgery; self-affirmation; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Change in the level of state anxiety on 3 consecutive days

  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.

  During 3 days, one measurement per day

Secondary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Positive Self-Affirmation

Control Group

NO INTERVENTION

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

Interventions

Positive Self-Affirmation BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Mehmet Akif Ersoy Thoracic and Cardiovacular Surgery Training and Research Hospital

Istanbul, 34290, Turkey (Türkiye)

Location

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  PMID: 37423676 DERIVED

MeSH Terms

Conditions

Heart Diseases; Anxiety Disorders

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Mental Disorders

Study Officials

• Meltem Yildirim, PhD

  University of Vic - Central University of Catalonia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Model Details: Randomised assignation of participants into two study groups: Intervention and Control.

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: August 4, 2022
• Study Start: July 30, 2019
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2020
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)