The Effect of Music Therapy and Breathing Exercise on Anxiety and Pain in Patients Undergoing Coronary Angiography

NCT06264960 | Completed

• 1 other identifier: E10208771
• Study Type: interventional
• Target: 512
• Locations: 1 country
• Sites: 2

Brief Summary

Coronary angiography serves as the primary diagnostic technique for cardiovascular disease. However, this invasive procedure commonly triggers pain, anxiety, and fear in patients. The objective of this randomized controlled trial was to examine the impact of music and breathing exercises on anxiety and pain levels in individuals undergoing coronary angiography. The study, conducted as a single-blind, randomized controlled trial, involved a sample of 165 patients, with 55 in each group: the control group, the breathing exercise group, and the music therapy group. Patients in the music group listened to music during angiography, those in the breathing exercise group practiced exercises 30 minutes before the procedure, while the control group received standard treatment. Anxiety levels were assessed both before and after the procedure, and pain levels were measured post-procedure. The study strictly adhered to the CONSORT statement guidelines.

Conditions

Procedural Pain; Procedural Anxiety

Outcome Measures

Primary Outcomes (2)

• State-Trait Anxiety Inventory

  State-Trait Anxiety Inventory (STAI), originally developed by Spielberg et al. to assess state and trait anxiety levels separately, has been adapted into the Turkish language by Öner and Le Compte. Validation and reliability studies for the Turkish version have been conducted, confirming its robustness. The scale consists of 40 items, with 20 items measuring state anxiety and 20 items measuring trait anxiety. Respondents were instructed to choose the response that best fits each item on the scale: "almost never," "sometimes," "often," or "almost always." Higher scores on the scale indicate greater levels of anxiety

  an average of 6 months

• Visual Analog Scale

  It is a scale used to assess pain intensity. Visual Analog Scale (VAS) is stated to be more sensitive and reliable in measuring pain intensity compared to other single-dimensional scales. The VAS is a 10 cm ruler that can be used horizontally and vertically, with "0" representing no pain at one end and "10" representing the most severe pain at the other end. The patient marks the level of pain intensity they are experiencing on this ruler. Pain severity scores were measured in millimetres.

  an average of 6 months

Study Arms (3)

Music therapy

ACTIVE COMPARATOR

After the patient was taken to the angiography laboratory, music was played using a digital MP3 player approximately 10 minutes before the angiography procedure began.

Behavioral: Music therapy

Breathing exercise

ACTIVE COMPARATOR

Individuals in the breathing exercise group were made to do breathing exercises by the researcher in the patient room 30 minutes before coronary angiography

Behavioral: Breathing exercise

Control Group

NO INTERVENTION

All data collection steps were applied identically to the control group patients, except for music application and deep breathing exercises. All patients in the study group received the same routine care.

Interventions

Music therapy BEHAVIORAL

After the patient was admitted to the angiography laboratory, approximately 10 minutes before the angiography procedure commenced, they were seated and allowed to relax. Music was played using a digital MP3 player.

Music therapy

Breathing exercise BEHAVIORAL

Individuals in the breathing exercise group were made to do breathing exercises by the researcher in the patient room 30 minutes before coronary angiography. The exercises were performed in a single patient room, in a quiet and calm environment. During the first 5 minutes, the researcher explained how the exercise was done with pictures and showed it to the patient. The patient was then asked to do the exercise for 10 minutes under the supervision of the researcher.

Breathing exercise

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: It is based on self-representation of gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• being scheduled for their first coronary angiography
• being above 18 years of age
• not being dependent on drugs or alcohol
• having orientation to time and place
• not experiencing respiratory distress
• not having a history of serious psychological problems in the past 6 months
• not taking any medication that suppresses anxiety symptoms and pain

You may not qualify if:

• Patients who did not like music due to cultural reasons
• stents implanted during angioplasty
• required urgent treatment for the management of cardiac arrhythmias
• had hearing problems,
• had difficulty performing breathing exercises

Sponsors & Collaborators

• Ulku Gunes: lead

Study Sites (2)

Ege University

Bornova, İzmir, 35100, Turkey (Türkiye)

Location

Ülkü Güneş

Bornova, İzmir, 35100, Turkey (Türkiye)

Location

Related Publications (4)

• Oyur Celik G, Guzelcicek A, Celik S. The Effects of Music Therapy on Patients With Coronary Artery Disease Before the Invasive Procedure: A Randomized Controlled Study. J Perianesth Nurs. 2022 Apr;37(2):194-198. doi: 10.1016/j.jopan.2021.01.010. Epub 2021 Dec 28.

  PMID: 34969619 RESULT

• Ho CY, Wexberg P, Schneider B, Stollberger C. Effect of music on patients with cardiovascular diseases and during cardiovascular interventions : A systematic review. Wien Klin Wochenschr. 2021 Aug;133(15-16):790-801. doi: 10.1007/s00508-020-01782-y. Epub 2020 Dec 9.

  PMID: 33296028 RESULT

• Ebrahimi R, Shroyer AL, Dennis P, Currier J, Lendvai Wischik D. Music Can Reduce the Need for Pharmacologic Conscious Sedation During Invasive Coronary Angiography. J Invasive Cardiol. 2020 Nov;32(11):440-444. doi: 10.25270/jic/20.00132. Epub 2020 Oct 22.

  PMID: 33087584 RESULT

• Baljon KJ, Romli MH, Ismail AH, Khuan L, Chew BH. Effectiveness of breathing exercises, foot reflexology and back massage (BRM) on labour pain, anxiety, duration, satisfaction, stress hormones and newborn outcomes among primigravidae during the first stage of labour in Saudi Arabia: a study protocol for a randomised controlled trial. BMJ Open. 2020 Jun 15;10(6):e033844. doi: 10.1136/bmjopen-2019-033844.

  PMID: 32540887 RESULT

Related Links

• The Effects of Music Therapy on Patients With Coronary Artery Disease Before the Invasive Procedure: A Randomized Controlled Study
• Effect of music on patients with cardiovascular diseases and during cardiovascular interventions : A systematic review
• Music Can Reduce the Need for Pharmacologic Conscious Sedation During Invasive Coronary Angiography
• Effectiveness of breathing exercises, foot reflexology and back massage

MeSH Terms

Conditions

Pain, Procedural

Interventions

Music Therapy; Breathing Exercises

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Mind-Body Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• ülkü güneş, Prof.

  Ege University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The nurse responsible for conducting all measurements, including pain and anxiety assessments using the Visual Analog Scale (VAS) and State-Trait Anxiety Inventory (STAI), was not part of the research team. The nurse, being independent and not aware of the participants' group assignments, helps to ensure that the assessments are conducted impartially, without knowledge of which intervention each participant received.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Profesor

Model Details: This single-center, single-blind, randomized controlled trial was conducted in Izmir, Turkey, from July 2021 to July 2022. Participants were randomly assigned to one of three groups: intervention 1 (music), intervention 2 (breathing exercises), or control (standard care), in a 1:1:1 ratio.

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 20, 2024
• Study Start: September 15, 2022
• Primary Completion: May 30, 2023
• Study Completion: October 2, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

TU (2)