BreastfeedingNCT07090902
The Effect of Progressive Relaxation Exercise
A study testing Progressive Relaxation-Based Childbirth Preparation Program in people with Breastfeeding and Pregnancy, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
This clinical trial aims to evaluate the effect of a childbirth preparation program that includes progressive relaxation exercises on pregnant women's preferences for mode of delivery, their experience of labour pain, and breastfeeding comfort. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Pregnancy, Labor Pain
- What is being tested?
- Progressive Relaxation-Based Childbirth Preparation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2025to 20 Oct 2025
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female participants aged between 18 and 49 years
- Currently pregnant
- Willing to participate in the study and provide informed consent
- Able to attend the planned training sessions regularly
- No complications during pregnancy, childbirth, or postpartum for themselves or their newborn
Who cannot join
- Not within the age range of 18-49
- Not currently pregnant
- Fails to complete study questionnaires or withdraws from the study
- Has communication difficulties or cognitive impairment
- Fails to attend training sessions regularly
- Has open wounds or allergic skin conditions
Show all 13Show fewer
- Develops postpartum complications (e.g., bleeding, infection, fever)
- Has cardiac arrhythmia or uses a pacemaker
- Diagnosed with conditions such as epilepsy or pre-eclampsia
- Has kidney or liver disease
- Previously practiced progressive muscle relaxation techniques
- Is morbidly obese (BMI > 40)
- Uses chronic opioids, antidepressants, or psychoactive medications
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun Training and Research Hospital, Department of Obstetrics and Gynecology
Samsun, Karabük Province, 78500
About this study
Official title: Effect of Childbirth Preparation Education Using Progressive Relaxation Exercise on Birth Mode Preference, Labor Pain and Breastfeeding Comfort
This clinical trial aims to evaluate the effect of a childbirth preparation program that includes progressive relaxation exercises on pregnant women's preferences for mode of delivery, their experience of labour pain, and breastfeeding comfort. Participants in the intervention group will receive a specially developed educational booklet and an audio CD with guided exercises, along with face-to-face training sessions. The control group will receive standard prenatal care. The study will help determine whether relaxation-based training can support women in coping with labour more comfortably and influence their choices and early postpartum experiences.
Read the detailed description
This study is a randomized controlled trial designed to evaluate the effectiveness of a childbirth preparation education program that incorporates progressive relaxation exercises. The intervention was developed to address the physical and psychological challenges pregnant women face, particularly in managing labour pain, making informed decisions about mode of delivery, and achieving comfort in early breastfeeding.
The study will be conducted in four stages. First, a childbirth preparation booklet including progressive relaxation techniques will be created based on current literature and expert guidance. Second, the content will be reviewed by a panel of experts to ensure content validity. Third, eligible pregnant women will receive in-person training sessions supported by the booklet and a relaxation exercise CD developed by the Turkish Psychological Association. Lastly, participants will be instructed to practice the exercises daily at home, and the effectiveness of the intervention will be evaluated using validated measurement tools.
The trial will be conducted in Samsun, Türkiye, and will include 40 pregnant women meeting specific inclusion criteria. Participants will be randomly assigned to either the intervention group or the control group. Outcomes will be measured using established scales such as the Visual Analogue Scale (VAS) for labour pain, LATCH for breastfeeding, and a postpartum comfort scale. The results of this study may contribute to the development of accessible, low-cost, and culturally appropriate childbirth education strategies in Türkiye and globally.
- Conditions
- Breastfeeding, Pregnancy, Labor Pain
- Being tested
- Progressive Relaxation-Based Childbirth Preparation Program
- Keywords
- Progressive relaxation exercise, labor pain, delivery method, breastfeeding
- Medical subject headings
- Breast Feeding, Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Relaxation-Based Childbirth Preparation ProgramBehavioural
Also called PMR-Enhanced Antenatal Program
This intervention consists of a childbirth preparation program that integrates progressive muscle relaxation (PMR) exercises. Participants receive face-to-face education by trained health professionals, a printed booklet explaining both childbirth preparation and PMR techniques, and an audio CD with guided relaxation sessions produced by the Turkish Psychological Association. The participants are instructed to perform the relaxation exercises daily at home until delivery. The goal of this intervention is to reduce labour pain, support informed mode of delivery preference, and enhance breastfeeding comfort in the early postpartum period.
| Study group | Role | What they receive |
|---|---|---|
| Progressive Relaxation-Based Childbirth Preparation Program | Experimental | A structured education program including progressive muscle relaxation techniques delivered through face-to-face instruction, printed materials, and a guided CD. Participants are asked to follow daily exercises at home until birth. Receives: Behavioral: Progressive Relaxation-Based Childbirth Preparation Program |
| Control Group | No intervention | Participants in this group will receive standard antenatal care provided by the hospital. No additional childbirth education or relaxation training will be offered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
During active labour (at 4-7 cm cervical dilation
Labour pain will be assessed using the Visual Analogue Scale (VAS), a 10-point self-reported pain scale. Higher scores indicate more intense pain.
Measured: within 5 hours after the start of labor
Secondary outcomes (3)
The type of birth and the type of birth they want during pregnancy.
The preferred and actual mode of delivery (vaginal vs. caesarean section) will be recorded and compared between intervention and control groups.
Measured: 36-38 weeks of pregnancy and within 2 days after birth
Breastfeeding Comfort
Breastfeeding comfort will be evaluated using the Postnatal Comfort Scale
Measured: Within 2 hours after delivery (Within 24 hours after delivery)
Pain Intensity Score
Pain intensity was measured using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain).
Measured: within 5 hours after the start of labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start25 Aug 2025
- Primary completion25 Sep 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies 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
- Model description
- This is a parallel-group, randomized controlled trial with two arms: one intervention group receiving childbirth preparation training with progressive relaxation exercises, and one control group receiving standard prenatal care.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reyhan Aydin Doğan, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090902
- Sponsor's protocol ID
- 2023/1493
- Other IDs
- KBÜBAP-24-YL-010
- Status last verified
- Jan 2026
- First submitted
- 20 Jun 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sercekus P, Baskale H. Effects of antenatal education on fear of childbirth, maternal self-efficacy and parental attachment. Midwifery. 2016 Mar;34:166-172. doi: 10.1016/j.midw.2015.11.016. Epub 2015 Nov 27.
PubMed 26656473Liu K, Chen Y, Wu D, Lin R, Wang Z, Pan L. Effects of progressive muscle relaxation on anxiety and sleep quality in patients with COVID-19. Complement Ther Clin Pract. 2020 May;39:101132. doi: 10.1016/j.ctcp.2020.101132. Epub 2020 Mar 6.
PubMed 32379667
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Childbirth Preparation Education Using Progressive Relaxation Exercise on Birth Mode Preference, Labor Pain and Breastfeeding Comfort
- ClinicalTrials.gov ID
- NCT07090902
- Acronym / sponsor ID
- 2023/1493
- Conditions
- Breastfeeding, Pregnancy, Labor Pain
- Keywords
- Progressive relaxation exercise, labor pain, delivery method, breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 29 Jul 2025 (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.
This clinical trial aims to evaluate the effect of a childbirth preparation program that includes progressive relaxation exercises on pregnant women's preferences for mode of delivery, their experience of labour pain, and breastfeeding comfort. Participants in the intervention group will receive a specially developed educational booklet and an audio CD with guided exercises, along with face-to-face training sessions. The control group will receive standard prenatal care. The study will help determine whether relaxation-based training can support women in coping with labour more comfortably and influence their choices and early postpartum experiences.
Detailed description
This study is a randomized controlled trial designed to evaluate the effectiveness of a childbirth preparation education program that incorporates progressive relaxation exercises. The intervention was developed to address the physical and psychological challenges pregnant women face, particularly in managing labour pain, making informed decisions about mode of delivery, and achieving comfort in early breastfeeding.
The study will be conducted in four stages. First, a childbirth preparation booklet including progressive relaxation techniques will be created based on current literature and expert guidance. Second, the content will be reviewed by a panel of experts to ensure content validity. Third, eligible pregnant women will receive in-person training sessions supported by the booklet and a relaxation exercise CD developed by the Turkish Psychological Association. Lastly, participants will be instructed to practice the exercises daily at home, and the effectiveness of the intervention will be evaluated using validated measurement tools.
The trial will be conducted in Samsun, Türkiye, and will include 40 pregnant women meeting specific inclusion criteria. Participants will be randomly assigned to either the intervention group or the control group. Outcomes will be measured using established scales such as the Visual Analogue Scale (VAS) for labour pain, LATCH for breastfeeding, and a postpartum comfort scale. The results of this study may contribute to the development of accessible, low-cost, and culturally appropriate childbirth education strategies in Türkiye and globally.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a parallel-group, randomized controlled trial with two arms: one intervention group receiving childbirth preparation training with progressive relaxation exercises, and one control group receiving standard prenatal care.
| Arm | Type | Receives |
|---|---|---|
| Progressive Relaxation-Based Childbirth Preparation Program | Experimental | Behavioral: Progressive Relaxation-Based Childbirth Preparation ProgramA structured education program including progressive muscle relaxation techniques delivered through face-to-face instruction, printed materials, and a guided CD. Participants are asked to follow daily exercises at home until birth. |
| Control Group | No intervention | –Participants in this group will receive standard antenatal care provided by the hospital. No additional childbirth education or relaxation training will be offered. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female participants aged between 18 and 49 years
- Currently pregnant
- Willing to participate in the study and provide informed consent
- Able to attend the planned training sessions regularly
- No complications during pregnancy, childbirth, or postpartum for themselves or their newborn
Key exclusion criteria (13 listed)
- Not within the age range of 18-49
- Not currently pregnant
- Fails to complete study questionnaires or withdraws from the study
- Has communication difficulties or cognitive impairment
- Fails to attend training sessions regularly
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 |
|---|---|---|
| Progressive Relaxation-Based Childbirth Preparation ProgramAlso: PMR-Enhanced Antenatal ProgramThis intervention consists of a childbirth preparation program that integrates progressive muscle relaxation (PMR) exercises. Participants receive face-to-face education by trained health professionals, a printed booklet explaining both childbirth preparation and PMR techniques, and an audio CD with guided relaxation sessions produced by the Turkish Psychological Association. The participants are instructed to perform the relaxation exercises daily at home until delivery. The goal of this intervention is to reduce labour pain, support informed mode of delivery preference, and enhance breastfeeding comfort in the early postpartum period. | Behavioural | Progressive Relaxation-Based Childbirth Preparation Program |
Primary outcome
During active labour (at 4-7 cm cervical dilation
Time frame: within 5 hours after the start of labor
Labour pain will be assessed using the Visual Analogue Scale (VAS), a 10-point self-reported pain scale. Higher scores indicate more intense pain.
3 secondary outcomes
The type of birth and the type of birth they want during pregnancy.
Time frame: 36-38 weeks of pregnancy and within 2 days after birth
Breastfeeding Comfort
Time frame: Within 2 hours after delivery (Within 24 hours after delivery)
Pain Intensity Score
Time frame: within 5 hours after the start of labor
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 21 Jan 2026.
- Results publication: PubMed 26656473Sercekus P, Baskale H. Effects of antenatal education on fear of childbirth, maternal self-efficacy and parental attachment. Midwifery. 2016 Mar;34:166-172. doi: 10.1016/j.midw.2015.11.016. Epub 2015 Nov 27.
- Results publication: PubMed 32379667Liu K, Chen Y, Wu D, Lin R, Wang Z, Pan L. Effects of progressive muscle relaxation on anxiety and sleep quality in patients with COVID-19. Complement Ther Clin Pract. 2020 May;39:101132. doi: 10.1016/j.ctcp.2020.101132. Epub 2020 Mar 6.
- 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 Progressive Relaxation-Based Childbirth Preparation Program in people with Breastfeeding and Pregnancy, run by Karabuk 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 5 inclusion and 13 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 21 Jan 2026. 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?
During active labour (at 4-7 cm cervical dilation (time frame: within 5 hours after the start of labor). 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 NCT07090902, which also lists 2 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 21 Jan 2026.