Labour PainsEFPCMUAPLBONCT07060339
Effect of Nonpharmacological Methods on The Active Phase Of Labour
A study testing Exercise Programme, Hot Shower Programme and Combined Application (Exercise + Hot Shower) in people with Labour Pains and Massage, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical trial is to evaluate the effects of methods such as exercise and hot showers applied during the active phase of labour on labour pain, labour duration, mode of delivery, newborn health, and the labour experience. Read more about this study
- Who is it for?
- Ages 18 to 45 days, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labour Pains, Massage, Exercise
- What is being tested?
- Exercise Programme, Hot Shower Programme and Combined Application (Exercise + Hot Shower)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jan 2023to 28 May 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 45 days
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- Multiparity,
- High-risk pregnancies were not included in the study sample.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Üsküdar Üniversitesi Sağlık Bilimleri Fakültesi, İstanbul, Ümraniye 34662
Istanbul, Ümraniye, 34662
About this study
Official title: The Effect of Pain Coping Methods Used in the Active Phase of Labour on Birth Outcomes
The aim of this clinical trial is to evaluate the effects of methods such as exercise and hot showers applied during the active phase of labour on labour pain, labour duration, mode of delivery, newborn health, and the labour experience. In addition, the safety of these methods in terms of maternal and infant health will also be observed.
The main questions it aims to answer are:
Read more
Do exercise and warm shower applications reduce labour pain?
Do these methods shorten the duration of labour?
Is there a relationship between exercise and warm shower applications and the mode of delivery (vaginal birth/caesarean section)?
Do these practices affect the newborn's APGAR score?
Do women who use these methods have a more positive birth experience?
Participants:
Women who have started labour, are between 38 and 42 weeks pregnant, are expecting a single baby, and are having their first birth.
Participants will be randomly assigned to one of four groups:
Exercise
Warm shower
Exercise + warm shower
Pharmacological intervention (control group)
What is expected of participants:
Participate in exercise, warm shower, breathing exercises, and massage applications (depending on the group they are in) throughout the labour process
Participate in monitoring and evaluations during clinical check-ups
Complete postpartum questionnaires and scales related to the birth experience
This clinical study is being conducted to scientifically evaluate the effectiveness of non-pharmacological methods used during childbirth and to improve the birth experience.
Read the detailed description
In the study, data were collected face-to-face with a single midwife. The data used in the study were the Informed Consent Form; the Informative Information Form developed by the researchers in line with the literature Information Form , the Birth Monitoring Form used during childbirth, the Visual Analogue Scale - VAS, the Postpartum Assessment Form, and the Birth Experience Scale.
- Conditions
- Labour Pains, Massage, Exercise
- Being tested
- Exercise Programme, Hot Shower Programme, Combined Application (Exercise + Hot Shower), Pharmacological Intervention
- Keywords
- Labour Pain, Active Phase, Pain Management Techniques, Birth Experience, Midwifery Care
- Medical subject headings
- Labor Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ProgrammeBehavioural
Midwifery care, breathing exercises, massage and exercise applications were performed on pregnant women in this group during the active phase of labour. Following breathing exercises, massage was applied for 10 minutes using different techniques according to rest and contraction intervals. Pain levels were assessed using the VAS before and after massage. After the massage, the exercise session began; the pregnant woman was first walked along a 50-metre corridor, followed by squatting, squat, four-legged positions, wall stretching movements, and pelvic tilt, swaying, and leg stretching exercises using a Pilates ball. Pain levels were measured using the VAS before and after all exercise applications.
Hot Shower ProgrammeBehavioural
In addition to midwifery care, breathing exercises, massage, and hot showers were administered in this group. Massage was administered for 10 minutes after the breathing exercises, and pain levels were measured using the VAS before and after the massage. After the massage, considering the risk of the pregnant woman falling, she was seated on a stool in the shower, and warm water at a temperature of 36.5-37.8 °C was applied to the lower abdomen and sacrum region during contractions for 15 minutes. To prevent chills, the application was repeated at 10-minute intervals, and pain levels before and after were again assessed using the VAS.
Combined Application (Exercise + Hot Shower)Behavioural
In addition to midwifery care, breathing exercises, massage, exercise and hot shower treatments were performed for this group. As in Groups 1 and 2, the application began with breathing exercises, followed by massage, exercise, and hot showers in sequence. Pain levels were assessed using the VAS before and after each application, and measurements were taken again during the massage. Ten-minute breaks were given between applications to allow the pregnant women to rest, and the applications were continued alternately.
Pharmacological InterventionBehavioural
In this study, the fourth group was evaluated as the intervention 4 group and was followed up in accordance with standard interventions frequently applied during the birth process. Pregnant women in this group received routine midwifery care, massage treatments to promote relaxation, and breathing exercises in accordance with hospital protocols. In addition, pharmacological pain management methods commonly used in the clinic were also applied in this group.
| Study group | Role | What they receive |
|---|---|---|
| 1. Intervention Group 1 - Exercise Programme | Experimental | Participants in this group were provided with midwifery care, breathing exercises, massage and exercise programmes during the active phase of labour. This group was formed to monitor the effects of exercise on the labour process. Receives: Behavioral: Exercise Programme |
| 2. Intervention Group 2 - Hot Shower Programme | Experimental | Participants in this group received midwifery care, breathing exercises, massage, and hot shower applications during the active phase of labour. This arm was designed to evaluate the effects of hot showers on labour pain, duration, and comfort. Receives: Behavioral: Hot Shower Programme |
| 3. Intervention Group 3 - Combined Application (Exercise + Hot Shower) | Experimental | In this group, midwifery care, breathing exercises, massage, exercise, and hot shower applications were applied together during the active phase of labour. This arm was designed to examine the effects of combining multiple non-pharmacological methods. Receives: Behavioral: Combined Application (Exercise + Hot Shower) |
| 4. Intervention Group - Pharmacological Intervention | Experimental | This group was monitored during the birth process with only midwifery care and routine pharmacological interventions. It serves as the standard care group that did not receive non-pharmacological interventions for comparison with other groups. Receives: Behavioral: Pharmacological Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Comparison Scale (Vizual Analogue Scale -VAS)
VAS was used before and after each intervention to assess the level of pain during the birth process. Repeated measurements were taken between applications to monitor changes in pain and measure the effectiveness of the interventions.
Measured: VAS is used repeatedly during the 4-5 cm, 6-7 cm, 8-9 cm and full dilation stages of labour, before and after massage, exercise and hot shower applications, and during intervention when necessary.
Birth Experience Scale (BES)
It consists of 22 items and has 4 sub-dimensions.
Measured: By assessing her overall satisfaction with the birth process, it measures how she felt about the birth process and her physical and emotional experiences. It was completed within 24 hours after birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start27 Jan 2023
- Primary completion12 Feb 2024
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labour PainsStudies 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
- The study sample was divided into four groups: Group 1 - Intervention Group - (midwife monitoring during labour, breathing exercises, exercise and massage), Group 2 - Intervention Group - (midwife monitoring during labour, breathing exercises, massage and hot shower), Group 3 intervention group (midwife monitoring during labour, breathing exercises, exercise, massage and hot shower) and 4. intervention group (midwife monitoring during labour and pharmacological interventions). Data were collected face-to-face with a single midwife.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba YILMAZ ESENCAN, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060339
- Sponsor's protocol ID
- 2023-2/27
- Acronym
- EFPCMUAPLBO
- Status last verified
- Jun 2025
- First submitted
- 28 May 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study will be published in Yöktez.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pain Coping Methods Used in the Active Phase of Labour on Birth Outcomes
- ClinicalTrials.gov ID
- NCT07060339
- Acronym / sponsor ID
- EFPCMUAPLBO / 2023-2/27
- Conditions
- Labour Pains, Massage, Exercise
- Keywords
- Labour Pain, Active Phase, Pain Management Techniques, Birth Experience, Midwifery Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 27 Jan 2023 (actual)
- Primary completion
- 12 Feb 2024 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 11 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.
The aim of this clinical trial is to evaluate the effects of methods such as exercise and hot showers applied during the active phase of labour on labour pain, labour duration, mode of delivery, newborn health, and the labour experience. In addition, the safety of these methods in terms of maternal and infant health will also be observed.
The main questions it aims to answer are:
Do exercise and warm shower applications reduce labour pain?
Do these methods shorten the duration of labour?
Is there a relationship between exercise and warm shower applications and the mode of delivery (vaginal birth/caesarean section)?
Do these practices affect the newborn's APGAR score?
Do women who use these methods have a more positive birth experience?
Participants:
Women who have started labour, are between 38 and 42 weeks pregnant, are expecting a single baby, and are having their first birth.
Participants will be randomly assigned to one of four groups:
Exercise
Warm shower
Exercise + warm shower
Pharmacological intervention (control group)
What is expected of participants:
Participate in exercise, warm shower, breathing exercises, and massage applications (depending on the group they are in) throughout the labour process
Participate in monitoring and evaluations during clinical check-ups
Complete postpartum questionnaires and scales related to the birth experience
This clinical study is being conducted to scientifically evaluate the effectiveness of non-pharmacological methods used during childbirth and to improve the birth experience.
Detailed description
In the study, data were collected face-to-face with a single midwife. The data used in the study were the Informed Consent Form; the Informative Information Form developed by the researchers in line with the literature Information Form , the Birth Monitoring Form used during childbirth, the Visual Analogue Scale - VAS, the Postpartum Assessment Form, and the Birth Experience Scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- The study sample was divided into four groups: Group 1 - Intervention Group - (midwife monitoring during labour, breathing exercises, exercise and massage), Group 2 - Intervention Group - (midwife monitoring during labour, breathing exercises, massage and hot shower), Group 3 intervention group (midwife monitoring during labour, breathing exercises, exercise, massage and hot shower) and 4. intervention group (midwife monitoring during labour and pharmacological interventions). Data were collected face-to-face with a single midwife.
| Arm | Type | Receives |
|---|---|---|
| 1. Intervention Group 1 - Exercise Programme | Experimental | Behavioral: Exercise ProgrammeParticipants in this group were provided with midwifery care, breathing exercises, massage and exercise programmes during the active phase of labour. This group was formed to monitor the effects of exercise on the labour process. |
| 2. Intervention Group 2 - Hot Shower Programme | Experimental | Behavioral: Hot Shower ProgrammeParticipants in this group received midwifery care, breathing exercises, massage, and hot shower applications during the active phase of labour. This arm was designed to evaluate the effects of hot showers on labour pain, duration, and comfort. |
| 3. Intervention Group 3 - Combined Application (Exercise + Hot Shower) | Experimental | Behavioral: Combined Application (Exercise + Hot Shower)In this group, midwifery care, breathing exercises, massage, exercise, and hot shower applications were applied together during the active phase of labour. This arm was designed to examine the effects of combining multiple non-pharmacological methods. |
| 4. Intervention Group - Pharmacological Intervention | Experimental | Behavioral: Pharmacological InterventionThis group was monitored during the birth process with only midwifery care and routine pharmacological interventions. It serves as the standard care group that did not receive non-pharmacological interventions for comparison with other groups. |
Who may qualify
- Ages
- 18 to 45 days
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Multiparity,
- High-risk pregnancies were not included in the study sample.
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 |
|---|---|---|
| Exercise ProgrammeMidwifery care, breathing exercises, massage and exercise applications were performed on pregnant women in this group during the active phase of labour. Following breathing exercises, massage was applied for 10 minutes using different techniques according to rest and contraction intervals. Pain levels were assessed using the VAS before and after massage. After the massage, the exercise session began; the pregnant woman was first walked along a 50-metre corridor, followed by squatting, squat, four-legged positions, wall stretching movements, and pelvic tilt, swaying, and leg stretching exercises using a Pilates ball. Pain levels were measured using the VAS before and after all exercise applications. | Behavioural | 1. Intervention Group 1 - Exercise Programme |
| Hot Shower ProgrammeIn addition to midwifery care, breathing exercises, massage, and hot showers were administered in this group. Massage was administered for 10 minutes after the breathing exercises, and pain levels were measured using the VAS before and after the massage. After the massage, considering the risk of the pregnant woman falling, she was seated on a stool in the shower, and warm water at a temperature of 36.5-37.8 °C was applied to the lower abdomen and sacrum region during contractions for 15 minutes. To prevent chills, the application was repeated at 10-minute intervals, and pain levels before and after were again assessed using the VAS. | Behavioural | 2. Intervention Group 2 - Hot Shower Programme |
| Combined Application (Exercise + Hot Shower)In addition to midwifery care, breathing exercises, massage, exercise and hot shower treatments were performed for this group. As in Groups 1 and 2, the application began with breathing exercises, followed by massage, exercise, and hot showers in sequence. Pain levels were assessed using the VAS before and after each application, and measurements were taken again during the massage. Ten-minute breaks were given between applications to allow the pregnant women to rest, and the applications were continued alternately. | Behavioural | 3. Intervention Group 3 - Combined Application (Exercise + Hot Shower) |
| Pharmacological InterventionIn this study, the fourth group was evaluated as the intervention 4 group and was followed up in accordance with standard interventions frequently applied during the birth process. Pregnant women in this group received routine midwifery care, massage treatments to promote relaxation, and breathing exercises in accordance with hospital protocols. In addition, pharmacological pain management methods commonly used in the clinic were also applied in this group. | Behavioural | 4. Intervention Group - Pharmacological Intervention |
Primary outcome
Visual Comparison Scale (Vizual Analogue Scale -VAS)
Time frame: VAS is used repeatedly during the 4-5 cm, 6-7 cm, 8-9 cm and full dilation stages of labour, before and after massage, exercise and hot shower applications, and during intervention when necessary.
VAS was used before and after each intervention to assess the level of pain during the birth process. Repeated measurements were taken between applications to monitor changes in pain and measure the effectiveness of the interventions.
Birth Experience Scale (BES)
Time frame: By assessing her overall satisfaction with the birth process, it measures how she felt about the birth process and her physical and emotional experiences. It was completed within 24 hours after birth.
It consists of 22 items and has 4 sub-dimensions.
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 Jul 2025.
- Gong, M., Dong, H., Tang, Y., Huang, W., \& Lu, F. (2020). Aromaterapinin kaygı üzerindeki etkileri: Randomize kontrollü denemelerin meta analizi. Duygusal Bozukluklar Dergisi, 274, 1028-1040.Link provided by the sponsor.
- Uysal, C., Boz, İ., \& Salman, S. (2022). Doğum Eyleminin Aktif Fazında Yaşanan Bel Ağrısının Yönetiminde Steril Su Enjeksiyonunun Etkisi: Randomize, Plasebo Kontrollü Bir Çalışma. Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi, 15(2), 1Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The study will be published in Yöktez.
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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 Exercise Programme, Hot Shower Programme and Combined Application (Exercise + Hot Shower) in people with Labour Pains and Massage, run by Uskudar 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 0 inclusion and 2 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 Jul 2025. 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 Comparison Scale (Vizual Analogue Scale -VAS) (time frame: VAS is used repeatedly during the 4-5 cm, 6-7 cm, 8-9 cm and full dilation stages of labour, before and after massage, exercise and hot shower applications, and during intervention when necessary.). 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?
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 Jul 2025.