Labor PainNCT06035172
The Effect of Guided Imagery and Music Play on Labor Pain, Anxiety, and Birth Experience
A study testing guided imagery and music recital in people with Labor Pain, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Purpose: The aim of this project is to examine the effects of guided imagery and music performance during labor on labor pain, anxiety and birth experience. Methods: The research to be carried out within the scope of the project is randomized controlled and has an experimental research design. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- guided imagery and music recital
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 31 Mar 2024
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being between the ages of 18-35,
- Primiparous and singleton pregnancy,
- No risky pregnancy,
- At 38 to 42 weeks of pregnancy,
- Being literate and able to speak and understand Turkish,
- Pregnant women with a cervical dilation of 4 to 5 cm.
Who cannot join
- Being under the age of 18,
- Presence of chronic disease,
- Women who became pregnant as a result of the application of assisted reproductive techniques,
- Hearing problem,
- Having a known diagnosis of serious psychiatric illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Guided Imagery and Music Play on Labor Pain, Anxiety, and Birth Experience: A Randomized Controlled Study
Purpose: The aim of this project is to examine the effects of guided imagery and music performance during labor on labor pain, anxiety and birth experience.
Methods: The research to be carried out within the scope of the project is randomized controlled and has an experimental research design. The population of the research consists of primiparous pregnant women who applied to the Istanbul Provincial Health Directorate, Istanbul Training and Research Hospital, Suleymaniye Obstetrics and Pediatrics Additional Service Building, Birth Unit. Eligible participants in the study sample will be randomly selected at a 1:1:1 ratio. In the calculation of the sample size, using the G*Power (3.1.9.2) program, 5% first type error, 0.30 standardized effect size, distribution ratio to 1 groups, 90% power considering data loss, and the minimum sample size required for 3 groups was 144 people in total. calculated as 48 cases for each group. The group of pregnant women who meet the inclusion criteria will be determined by using the "Randomizer.org" program. In this direction, 48 people (guided imagery) should be included in experiment 1, 48 people in experiment 2 (musical concert) and 48 people in control group. "Informed Consent Form" and "Voluntary Consent Form" will be presented to the pregnant women included in the study, by giving information about the study."Personal Information Form", "Visual Analogue Scale (VAS)", "State Trait Anxiety Scale (STAI Form TX-1)" and "Birth Expectations and Experiences Scale-Part 1 (DBSS-1)" will be applied to pregnant women assigned to the Guided Imagery Group. . In the active phase of labor, when the cervical opening is measured as 4-5 cm, 6-7 cm and 8-10 cm, a 15-minute guided imagery concert (of the scenario determined for the birth process) prepared by the researchers within the scope of the literature, with the service of a ney artist and a psychological counselor, is played by bluetooth from an MP3 player. The pregnant woman will be listened to by the researcher through headphones. "VAS" will be applied after each attempt. 1 hour after the birth of the baby and placenta, data will be collected by applying "VAS", "STAI Form TX-1" and "Birth Expectations and Experiences Scale-Part 2 (DBSS-2)".
"Personal Information Form", "VAS", "STAI Form TX-1" and "DBSS-1" will be applied to pregnant women assigned to the music concert group. In the active phase of labor, when the cervical opening is measured as 4-5 cm, 6-7 cm and 8-10 cm, the 15-minute ney concert in the acemasiran tune (instrumental music), which was prepared by the researchers with the service of the ney artist within the scope of the literature (the scenario determined for the birth process), was played from the MP3 player via bluetooth headphones. The pregnant woman will be listened to by the researcher. "VAS" will be applied after each attempt. Data will be collected by applying "VAS", "STAI Form TX-1" and "DBSS-2" 1 hour after the birth of the baby and placenta.
- Conditions
- Labor Pain
- Being tested
- guided imagery, music recital
- Keywords
- Birth pain, music listening, positive birth, guided imagery
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guided imageryBehavioural
The guided imagery technique, which is one of these methods, is used in the method of pain by establishing a connection between mind and body. In the technique, a peaceful scene is depicted in which positive energy is reflected in the person to ensure complete relaxation and relaxation.
music recitalBehavioural
It is stated that the acemasiran tune (instrumental music) has a reducing effect on the duration of labor, as well as having labor pain and muscle relaxant properties.
| Study group | Role | What they receive |
|---|---|---|
| guided imagery group | Experimental | Not described Receives: Behavioral: guided imagery |
| music group | Experimental | Not described Receives: Behavioral: music recital |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of labor pain
labor pain assessed by VAS
Measured: 15 minutes
Reduction of Anxiety
anxieties of vaginal birth assessed by STAI Form TX-1
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Mar 2023
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betul Uncu, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035172
- Sponsor's protocol ID
- 2022/362
- Status last verified
- May 2024
- First submitted
- 11 Jul 2023
- Last updated
- 28 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Biana CB, Cecagno D, Porto AR, Cecagno S, Marques VA, Soares MC. Non-pharmacological therapies applied in pregnancy and labor: an integrative review. Rev Esc Enferm USP. 2021 Apr 16;55:e03681. doi: 10.1590/S1980-220X2019019703681. eCollection 2021. English, Portuguese.
PubMed 33886910Rantala A, Hakala M, Polkki T. Women's perceptions of the pain assessment and non-pharmacological pain relief methods used during labor: A cross-sectional survey. Eur J Midwifery. 2022 Apr 13;6:21. doi: 10.18332/ejm/146136. eCollection 2022.
PubMed 35515089Smith CA, Levett KM, Collins CT, Armour M, Dahlen HG, Suganuma M. Relaxation techniques for pain management in labour. Cochrane Database Syst Rev. 2018 Mar 28;3(3):CD009514. doi: 10.1002/14651858.CD009514.pub2.
PubMed 29589650Mirghafourvand M, Mohammad Alizadeh Charandabi S, Ghanbari-Homayi S, Jahangiry L, Nahaee J, Hadian T. Effect of birth plans on childbirth experience: A systematic review. Int J Nurs Pract. 2019 Aug;25(4):e12722. doi: 10.1111/ijn.12722. Epub 2019 Jan 24.
PubMed 30675962Kacar N, Ozcan Keser N. Comparison of the effect of mechanical massage and warm mechanical massage application on perceived labor pain and childbirth experience: A randomized clinical trial. Eur J Midwifery. 2021 Feb 27;5:5. doi: 10.18332/ejm/132883. eCollection 2021.
PubMed 33655203
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Guided Imagery and Music Play on Labor Pain, Anxiety, and Birth Experience: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06035172
- Acronym / sponsor ID
- 2022/362
- Conditions
- Labor Pain
- Keywords
- Birth pain, music listening, positive birth, guided imagery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 13 Sep 2023 (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.
Purpose: The aim of this project is to examine the effects of guided imagery and music performance during labor on labor pain, anxiety and birth experience.
Methods: The research to be carried out within the scope of the project is randomized controlled and has an experimental research design. The population of the research consists of primiparous pregnant women who applied to the Istanbul Provincial Health Directorate, Istanbul Training and Research Hospital, Suleymaniye Obstetrics and Pediatrics Additional Service Building, Birth Unit. Eligible participants in the study sample will be randomly selected at a 1:1:1 ratio. In the calculation of the sample size, using the G*Power (3.1.9.2) program, 5% first type error, 0.30 standardized effect size, distribution ratio to 1 groups, 90% power considering data loss, and the minimum sample size required for 3 groups was 144 people in total. calculated as 48 cases for each group. The group of pregnant women who meet the inclusion criteria will be determined by using the "Randomizer.org" program. In this direction, 48 people (guided imagery) should be included in experiment 1, 48 people in experiment 2 (musical concert) and 48 people in control group. "Informed Consent Form" and "Voluntary Consent Form" will be presented to the pregnant women included in the study, by giving information about the study."Personal Information Form", "Visual Analogue Scale (VAS)", "State Trait Anxiety Scale (STAI Form TX-1)" and "Birth Expectations and Experiences Scale-Part 1 (DBSS-1)" will be applied to pregnant women assigned to the Guided Imagery Group. . In the active phase of labor, when the cervical opening is measured as 4-5 cm, 6-7 cm and 8-10 cm, a 15-minute guided imagery concert (of the scenario determined for the birth process) prepared by the researchers within the scope of the literature, with the service of a ney artist and a psychological counselor, is played by bluetooth from an MP3 player. The pregnant woman will be listened to by the researcher through headphones. "VAS" will be applied after each attempt. 1 hour after the birth of the baby and placenta, data will be collected by applying "VAS", "STAI Form TX-1" and "Birth Expectations and Experiences Scale-Part 2 (DBSS-2)".
"Personal Information Form", "VAS", "STAI Form TX-1" and "DBSS-1" will be applied to pregnant women assigned to the music concert group. In the active phase of labor, when the cervical opening is measured as 4-5 cm, 6-7 cm and 8-10 cm, the 15-minute ney concert in the acemasiran tune (instrumental music), which was prepared by the researchers with the service of the ney artist within the scope of the literature (the scenario determined for the birth process), was played from the MP3 player via bluetooth headphones. The pregnant woman will be listened to by the researcher. "VAS" will be applied after each attempt. Data will be collected by applying "VAS", "STAI Form TX-1" and "DBSS-2" 1 hour after the birth of the baby and placenta.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| guided imagery group | Experimental | Behavioral: guided imagery |
| music group | Experimental | Behavioral: music recital |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Being between the ages of 18-35,
- Primiparous and singleton pregnancy,
- No risky pregnancy,
- At 38 to 42 weeks of pregnancy,
- Being literate and able to speak and understand Turkish,
Key exclusion criteria (5 listed)
- Being under the age of 18,
- Presence of chronic disease,
- Women who became pregnant as a result of the application of assisted reproductive techniques,
- Hearing problem,
- Having a known diagnosis of serious psychiatric illness.
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 |
|---|---|---|
| guided imageryThe guided imagery technique, which is one of these methods, is used in the method of pain by establishing a connection between mind and body. In the technique, a peaceful scene is depicted in which positive energy is reflected in the person to ensure complete relaxation and relaxation. | Behavioural | guided imagery group |
| music recitalIt is stated that the acemasiran tune (instrumental music) has a reducing effect on the duration of labor, as well as having labor pain and muscle relaxant properties. | Behavioural | music group |
Primary outcome
Reduction of labor pain
Time frame: 15 minutes
labor pain assessed by VAS
Reduction of Anxiety
Time frame: 15 minutes
anxieties of vaginal birth assessed by STAI Form TX-1
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 28 Oct 2024.
- Background: PubMed 33886910Biana CB, Cecagno D, Porto AR, Cecagno S, Marques VA, Soares MC. Non-pharmacological therapies applied in pregnancy and labor: an integrative review. Rev Esc Enferm USP. 2021 Apr 16;55:e03681. doi: 10.1590/S1980-220X2019019703681. eCollection 2021. English, Portuguese.
- Background: PubMed 35515089Rantala A, Hakala M, Polkki T. Women's perceptions of the pain assessment and non-pharmacological pain relief methods used during labor: A cross-sectional survey. Eur J Midwifery. 2022 Apr 13;6:21. doi: 10.18332/ejm/146136. eCollection 2022.
- Background: PubMed 29589650Smith CA, Levett KM, Collins CT, Armour M, Dahlen HG, Suganuma M. Relaxation techniques for pain management in labour. Cochrane Database Syst Rev. 2018 Mar 28;3(3):CD009514. doi: 10.1002/14651858.CD009514.pub2.
- Background: PubMed 30675962Mirghafourvand M, Mohammad Alizadeh Charandabi S, Ghanbari-Homayi S, Jahangiry L, Nahaee J, Hadian T. Effect of birth plans on childbirth experience: A systematic review. Int J Nurs Pract. 2019 Aug;25(4):e12722. doi: 10.1111/ijn.12722. Epub 2019 Jan 24.
- Background: PubMed 33655203Kacar N, Ozcan Keser N. Comparison of the effect of mechanical massage and warm mechanical massage application on perceived labor pain and childbirth experience: A randomized clinical trial. Eur J Midwifery. 2021 Feb 27;5:5. doi: 10.18332/ejm/132883. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing guided imagery and music recital in people with Labor Pain, run by Istanbul University - Cerrahpasa at 1 site 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 6 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 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Reduction of labor pain (time frame: 15 minutes). 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 NCT06035172, which also lists 5 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 28 Oct 2024.