Procedural PainNCT06264960
The Effect of Music Therapy and Breathing Exercise on Anxiety and Pain in Patients Undergoing Coronary Angiography
A study testing Music therapy and Breathing exercise in people with Procedural Pain and Procedural Anxiety, run by Ulku Gunes at 2 sites in Turkey (Türkiye).
Trial summary
Coronary angiography serves as the primary diagnostic technique for cardiovascular disease. However, this invasive procedure commonly triggers pain, anxiety, and fear in patients. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Procedural Pain, Procedural Anxiety
- What is being tested?
- Music therapy and Breathing exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 512 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Sep 2022to 2 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ege University
Bornova, İzmir, 35100
Ülkü Güneş
Bornova, İzmir, 35100
About this study
Official title: The Effect of Music Therapy and Breathing Exercise on Anxiety and Pain in Patients Undergoing Coronary Angiography: A Randomised Controlled Study
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.
Read the detailed description
Breathing exercises and music therapy have been demonstrated to be used in managing anxiety and pain in many clinical conditions, only a few studies have investigated their effectiveness on anxiety and pain during coronary angiography. Pain and anxiety are commonly experienced symptoms during coronary angiography. Therefore, the objective of this study is to examine the effects of the music and breathing exercises on anxiety and pain in patients undergoing coronary angiography.
Design 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. The study received approval from the Ethics Review Committee of a university hospital, and written informed consent was obtained from each participant.
Sample The participants were selected by the researcher from patients who were scheduled to undergo coronary angiography at the Cardiology clinic of a university hospital. Patients were included in the study if they met the following criteria: 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, and consenting to participate in the study. 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, or had difficulty performing breathing exercises were excluded.
The sample size was calculated based on previous research on the effects of coronary angiography on pain and anxiety as well as our pilot study. We aimed to have a sufficient sample size to detect a difference of 2 units (mean ± SD) in pain levels between the intervention and control groups. 165 subjects were targeted for this study.
2.3. Randomization Eligible participants were randomly assigned to either the intervention groups or control group in a 1:1 ratio using a permuted block randomization method with a block size of 6. A random allocation sequence was generated by an off-site statistician who was not involved in participant recruitment. Allocation concealment was ensured by employing sealed opaque envelopes containing sequence numbers.
Intervention Breathing Group
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. If the patient performed the Deep Breathing Exercise correctly, the application was terminated. If unable, the patient was asked to practice for another 5 minutes. If the patient still could not perform the exercise correctly after this period, he was excluded from the sample. Deep Breathing Exercise was applied according to the Cleveland Clinic Guideline. The Cleveland Clinic guide showed how to do the Deep Breathing Exercise with the knee bent. The following protocol was followed in the breathing exercise:
- Ensure the patient is comfortably seated with bent knees, and relax the shoulders, head, and neck.
- Place one hand on the upper chest and the other below the rib cage to enable the patient to sense diaphragm movement.
- Initiate slow inhalation through the nose, allowing the abdominal region to expand outward.
- Maintain stability in the hand on the chest to minimize movement.
- Tighten the stomach muscles and exhale through pursed lips, facilitating the inward movement of the abdominal area.
- Keep the hand on the upper chest as stable as possible throughout the process.
Music Group 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. The music was compiled from Johann Sebastian Bach's light instrumental music albums. Previous studies have demonstrated that this album has a positive impact on the cardiovascular system. The duration of music listening ranged from 20 to 40 minutes depending on the length of the procedure. Since the patient could be given coughing instructions during the procedure, headphones could not be used. Individuals lying on the bed in the angiography room were instructed to assume a comfortable position and focus on the music.
Control Group 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.
Instruments Demographic variables and health characteristics of participants Demographic variables, such as age, education, marital status, and health characteristics (presence of chronic illnesses, coping mechanisms for stress, previous surgery history) were collected using a structured questionnaire.
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.
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.
Outcome measures The primary outcome measurement is the patients' pain and anxiety levels. Individuals were assigned to the study groups after being informed about the research and obtaining their written consent. Initially, basic patient information was collected and recorded on the "Patient Identification Form". Subsequently, individuals were provided with information on the use of the VAS and the angiography procedure. Following this, individuals were assessed using the STAI. Afterwards, patients were taken to the angiography laboratory. Immediately after the angiography procedure was completed, the individuals' pain levels were evaluated and documented using the VAS. Thirty minutes after the angiography procedure was completed, individuals underwent an assessment using the STAI. All of these measurements were conducted by a nurse who was not part of the research team.
- Conditions
- Procedural Pain, Procedural Anxiety
- Being tested
- Music therapy, Breathing exercise
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyBehavioural
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.
Breathing exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start15 Sep 2022
- Primary completion30 May 2023
- Study completion2 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulku Gunes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ulku Gunes, Ege University
- Investigators
- ülkü güneş, Prof., Study director, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264960
- Sponsor's protocol ID
- E10208771
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34969619Ho 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.
PubMed 33296028Ebrahimi 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.
PubMed 33087584Baljon 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.
PubMed 32540887
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Therapy and Breathing Exercise on Anxiety and Pain in Patients Undergoing Coronary Angiography: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06264960
- Acronym / sponsor ID
- E10208771
- Conditions
- Procedural Pain, Procedural Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- Ulku GunesUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 2 Oct 2023 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Breathing exercises and music therapy have been demonstrated to be used in managing anxiety and pain in many clinical conditions, only a few studies have investigated their effectiveness on anxiety and pain during coronary angiography. Pain and anxiety are commonly experienced symptoms during coronary angiography. Therefore, the objective of this study is to examine the effects of the music and breathing exercises on anxiety and pain in patients undergoing coronary angiography.
Design 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. The study received approval from the Ethics Review Committee of a university hospital, and written informed consent was obtained from each participant.
Sample The participants were selected by the researcher from patients who were scheduled to undergo coronary angiography at the Cardiology clinic of a university hospital. Patients were included in the study if they met the following criteria: 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, and consenting to participate in the study. 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, or had difficulty performing breathing exercises were excluded.
The sample size was calculated based on previous research on the effects of coronary angiography on pain and anxiety as well as our pilot study. We aimed to have a sufficient sample size to detect a difference of 2 units (mean ± SD) in pain levels between the intervention and control groups. 165 subjects were targeted for this study.
2.3. Randomization Eligible participants were randomly assigned to either the intervention groups or control group in a 1:1 ratio using a permuted block randomization method with a block size of 6. A random allocation sequence was generated by an off-site statistician who was not involved in participant recruitment. Allocation concealment was ensured by employing sealed opaque envelopes containing sequence numbers.
Intervention Breathing Group
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. If the patient performed the Deep Breathing Exercise correctly, the application was terminated. If unable, the patient was asked to practice for another 5 minutes. If the patient still could not perform the exercise correctly after this period, he was excluded from the sample. Deep Breathing Exercise was applied according to the Cleveland Clinic Guideline. The Cleveland Clinic guide showed how to do the Deep Breathing Exercise with the knee bent. The following protocol was followed in the breathing exercise:
- Ensure the patient is comfortably seated with bent knees, and relax the shoulders, head, and neck.
- Place one hand on the upper chest and the other below the rib cage to enable the patient to sense diaphragm movement.
- Initiate slow inhalation through the nose, allowing the abdominal region to expand outward.
- Maintain stability in the hand on the chest to minimize movement.
- Tighten the stomach muscles and exhale through pursed lips, facilitating the inward movement of the abdominal area.
- Keep the hand on the upper chest as stable as possible throughout the process.
Music Group 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. The music was compiled from Johann Sebastian Bach's light instrumental music albums. Previous studies have demonstrated that this album has a positive impact on the cardiovascular system. The duration of music listening ranged from 20 to 40 minutes depending on the length of the procedure. Since the patient could be given coughing instructions during the procedure, headphones could not be used. Individuals lying on the bed in the angiography room were instructed to assume a comfortable position and focus on the music.
Control Group 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.
Instruments Demographic variables and health characteristics of participants Demographic variables, such as age, education, marital status, and health characteristics (presence of chronic illnesses, coping mechanisms for stress, previous surgery history) were collected using a structured questionnaire.
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.
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.
Outcome measures The primary outcome measurement is the patients' pain and anxiety levels. Individuals were assigned to the study groups after being informed about the research and obtaining their written consent. Initially, basic patient information was collected and recorded on the "Patient Identification Form". Subsequently, individuals were provided with information on the use of the VAS and the angiography procedure. Following this, individuals were assessed using the STAI. Afterwards, patients were taken to the angiography laboratory. Immediately after the angiography procedure was completed, the individuals' pain levels were evaluated and documented using the VAS. Thirty minutes after the angiography procedure was completed, individuals underwent an assessment using the STAI. All of these measurements were conducted by a nurse who was not part of the research team.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Music therapy | Active comparator | Behavioral: Music therapyAfter the patient was taken to the angiography laboratory, music was played using a digital MP3 player approximately 10 minutes before the angiography procedure began. |
| Breathing exercise | Active comparator | Behavioral: Breathing exerciseIndividuals in the breathing exercise group were made to do breathing exercises by the researcher in the patient room 30 minutes before coronary angiography |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music therapyAfter 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. | Behavioural | Music therapy |
| Breathing exerciseIndividuals 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. | Behavioural | Breathing exercise |
Primary outcome
State-Trait Anxiety Inventory
Time frame: an average of 6 months
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
Visual Analog Scale
Time frame: an average of 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Results publication: PubMed 34969619Oyur 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.
- Results publication: PubMed 33296028Ho 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.
- Results publication: PubMed 33087584Ebrahimi 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.
- Results publication: PubMed 32540887Baljon 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.
- The Effects of Music Therapy on Patients With Coronary Artery Disease Before the Invasive Procedure: A Randomized Controlled StudyLink provided by the sponsor.
- Effect of music on patients with cardiovascular diseases and during cardiovascular interventions : A systematic reviewLink provided by the sponsor.
- Music Can Reduce the Need for Pharmacologic Conscious Sedation During Invasive Coronary AngiographyLink provided by the sponsor.
- Effectiveness of breathing exercises, foot reflexology and back massageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ülkü güneş, Prof. study director
Ege University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music therapy and Breathing exercise in people with Procedural Pain and Procedural Anxiety, run by Ulku Gunes at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anxiety Inventory (time frame: an average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06264960, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.