Labor PainNCT05317052
The Effect of Massage and Musıc Therapy on Birth Pain, Posttravmatic Comfort and Posttraumatic Development
A study testing Massage group in people with Labor Pain and Posttraumatic Growth, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
Birth pain is the most severe painful experience faced by primiparous people. Massage and music therapy reduce tension in the muscles and reduce the feeling of pain. Massage and music therapy will be applied to pregnant women. No intervention will be made to a group of pregnant women. Read more about this study
- Who is it for?
- Ages 19 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain, Posttraumatic Growth
- What is being tested?
- Massage group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2022to 1 Jul 2022
- 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 19 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Expectation of normal vaginal delivery
- Having a term pregnancy
- Being primiparous - Being in the active phase of labor (Cervical dilatation 4 cm)
- Single pregnancy
- Being in vertex presentation
- Uncomplicated prenatal process
- Volunteering to participate in the study
- Being pregnant without back pain
Who cannot join
- Pregnant women whose birth resulted in cesarean section due to failure of labor to progress during labor
- Pregnant women who did not undergo induction
- Pregnant women who underwent pharmacological intervention for labor pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: From Non-Pharmacologıcal Methods Applied to Primipars in Travay; The Effect of Massage And Music Therapy on Birth Pain, Posttravmatic Comfort and Posttraumatic Development: A Randomized Controlled Study
Birth pain is the most severe painful experience faced by primiparous people. Massage and music therapy reduce tension in the muscles and reduce the feeling of pain. Massage and music therapy will be applied to pregnant women. No intervention will be made to a group of pregnant women. Numerical Pain Assessment, Post Traumatic Development Scale and Birth Comfort Scale will be used in the research.
Read the detailed description
Birth pain is one of the most severe and difficult to control pains known. Non-pharmacological methods used to cope with labor pain are cheap and reliable. Massage and music therapy in the first stage of labor are non-pharmacological methods used to reduce labor pain. The purpose of this research; non-pharmacological methods applied to primiparous in labor; The aim of this study is to examine the effects of massage and music therapy on labor pain, postpartum comfort and posttraumatic development. A total of 114 primiparous pregnant women who had a normal delivery expectation and were in the active phase of labor (4-5 cm dilatation) were planned to be included in the study. Massage and music therapy will be applied to pregnant women. No intervention will be made to a group of pregnant women. Numerical Pain Assessment, Post Traumatic Development Scale and Birth Comfort Scale will be used in the research.
- Conditions
- Labor Pain, Posttraumatic Growth
- Being tested
- Massage group
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage groupBehavioural
Also called Music group
Massage and music therapy
| Study group | Role | What they receive |
|---|---|---|
| Massage | Experimental | Massage therapy Receives: Behavioral: Massage group |
| Music | Experimental | Music therapy Receives: Behavioral: Massage group |
| Control | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) Score
The score ranges from 1 to 10 peints, with increasing score reflecting more discomfort
Measured: In the labour (active and transition phase)
Secondary outcomes (2)
Postpartum Comfort Scale
It is possible to score between 34 and 170 on the scale. An increase in the scores obtained from the scale represents a high level of comfort.
Measured: At the enf of the delivery (In the 24 th hours)
Posttraumatic Growth Inventory
A minimum of 0 and a maximum of 105 points can be obtained from the scale. As the score obtained from the scale increases, it is thought that the level of post-traumatic development is higher.
Measured: At the enf of the delivery (In the 24 th hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start15 Apr 2022
- Primary completion1 Jun 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Akca, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317052
- Sponsor's protocol ID
- Amasya U
- Status last verified
- Feb 2023
- First submitted
- 30 Mar 2022
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Non-Pharmacologıcal Methods Applied to Primipars in Travay; The Effect of Massage And Music Therapy on Birth Pain, Posttravmatic Comfort and Posttraumatic Development: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05317052
- Acronym / sponsor ID
- Amasya U
- Conditions
- Labor Pain, Posttraumatic Growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 7 Apr 2022 (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.
Birth pain is the most severe painful experience faced by primiparous people. Massage and music therapy reduce tension in the muscles and reduce the feeling of pain. Massage and music therapy will be applied to pregnant women. No intervention will be made to a group of pregnant women. Numerical Pain Assessment, Post Traumatic Development Scale and Birth Comfort Scale will be used in the research.
Detailed description
Birth pain is one of the most severe and difficult to control pains known. Non-pharmacological methods used to cope with labor pain are cheap and reliable. Massage and music therapy in the first stage of labor are non-pharmacological methods used to reduce labor pain. The purpose of this research; non-pharmacological methods applied to primiparous in labor; The aim of this study is to examine the effects of massage and music therapy on labor pain, postpartum comfort and posttraumatic development. A total of 114 primiparous pregnant women who had a normal delivery expectation and were in the active phase of labor (4-5 cm dilatation) were planned to be included in the study. Massage and music therapy will be applied to pregnant women. No intervention will be made to a group of pregnant women. Numerical Pain Assessment, Post Traumatic Development Scale and Birth Comfort Scale will be used in the research.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Massage | Experimental | Behavioral: Massage groupMassage therapy |
| Music | Experimental | Behavioral: Massage groupMusic therapy |
| Control | No intervention | –Control |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Expectation of normal vaginal delivery
- Having a term pregnancy
- Being primiparous - Being in the active phase of labor (Cervical dilatation 4 cm)
- Single pregnancy
- Being in vertex presentation
Key exclusion criteria (3 listed)
- Pregnant women whose birth resulted in cesarean section due to failure of labor to progress during labor
- Pregnant women who did not undergo induction
- Pregnant women who underwent pharmacological intervention for labor pain
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 |
|---|---|---|
| Massage groupAlso: Music groupMassage and music therapy | Behavioural | Massage, Music |
Primary outcome
Visual Analog Scale (VAS) Score
Time frame: In the labour (active and transition phase)
The score ranges from 1 to 10 peints, with increasing score reflecting more discomfort
2 secondary outcomes
Postpartum Comfort Scale
Time frame: At the enf of the delivery (In the 24 th hours)
Posttraumatic Growth Inventory
Time frame: At the enf of the delivery (In the 24 th hours)
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 24 Feb 2023.
- 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 Massage group in people with Labor Pain and Posttraumatic Growth, run by Amasya University 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 8 inclusion and 3 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 24 Feb 2023. 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?
Visual Analog Scale (VAS) Score (time frame: In the labour (active and transition phase)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2023.