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

NCT05487430 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2022-08-04

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery and Research Hospital

    collaborator UNKNOWN
  • Trakya University

    collaborator OTHER
  • University of Vic - Central University of Catalonia

    lead OTHER

Principal Investigators

  • Meltem Yildirim, PhD · University of Vic - Central University of Catalonia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-30
Primary Completion
2020-03-20
Completion
2020-03-20

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05487430 on ClinicalTrials.gov