Labor PainNCT06263894
Alexander Technique on Labor Pain and Anxiety
A study testing Experimental group in people with Labor Pain and Anxiety, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This study will examine the effect of the Alexander Technique on labor pain and anxiety during labor. This study is designed as a randomized controlled experimental study. The population of the study consists of primiparous pregnant women who applied to Istanbul Provincial Health Directorate Başakşehir Çam and Sakura… 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, Anxiety
- What is being tested?
- Experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2024to 2 Jul 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
- Volunteer to participate in the study,
- Between the ages of 18-35,
- Primiparous and singleton pregnant,
- Women at term (between 37 and 41 weeks of gestation) will be included in the study.
Who cannot join
- Risky pregnancies,
- Women who become pregnant as a result of assisted reproductive techniques,
- Delivery by caesarean section,
- Wanting to leave without working,
- Women undergoing analgesia at any stage of the labor process will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Başakşehir Çam and Sakura City Hospital
Istanbul
Ayşen Özgür, +905393806296, aysenozgurr@gmail.com
About this study
Official title: The Effect of the Alexander Technique on Labor Pain and Anxiety: A Randomized Controlled Trial
This study will examine the effect of the Alexander Technique on labor pain and anxiety during labor. This study is designed as a randomized controlled experimental study. The population of the study consists of primiparous pregnant women who applied to Istanbul Provincial Health Directorate Başakşehir Çam and Sakura City Hospital, D-Block Maternity Hospital between November 2023 and May 2024. In calculating the sample size, G*Power (3.1.9.6) program was used to calculate the sample size with an error of 0.05, effect level of 0.5, power of 95%, and the required sample size for 2 groups was calculated as 34 people for each group with a total of 68 people.
Read the detailed description
Pain during childbirth has been described as the most severe pain women experience throughout their life course. Labor pain is a result of physiologic changes in the uterus. Pharmacologic and nonpharmacologic methods are used in the management of pain, which is a physiologic process. Nonpharmacological methods help women to feel comfortable in labor and contribute to women to have a positive birth experience by providing relaxation and reducing pain perception through cognitive, psychological and physical methods (Adil et al., 2020; Thompson et al. 2019). In addition, midwives who are with the woman during the birth process use non-pharmacological methods in an independent role in the management of labor pain, and this is also effective in alleviating the burden on current health expenditures. Alexander Technique appears as a non-pharmacologic method. In the literature, there is no study on the application of the Alexander Technique in the management of labor pain. It is assumed that the current posture and position to be provided with the Alexander Technique will be effective on pain and anxiety during the birth process. It is necessary to conduct studies on the use of the Alexander Technique in the birth process and evaluate the results.
This study will be the first study on the Alexander Technique to be applied to women in labor. The research to be conducted is planned as a randomized controlled experimental study. The population of the study consists of 68 primiparous pregnant women who applied to Istanbul Provincial Health Directorate Başakşehir Çam and Sakura City Hospital, D-Block Maternity Hospital between November 2023 and May 2024. Simple random sampling method will be used for the sample of the study. Pregnant women included in the study will be informed about the study and 'Informed Consent Form' and 'Voluntary Consent Form' will be filled. 'Personal Information Form', 'Visual Analog Scale (VAS)', 'Beck Anxiety Scale (BAS)' and 'Oxford Birth Anxiety Scale (OWLS)' will be applied to the pregnant women included in the experimental group. After the initial data is collected, the principles in the Alexander Technique will be applied when the woman's cervical dilatation is 0-4 cm. The duration of the application is approximately 15 minutes and the researcher will take an active role with the woman accompanied by a counselor during this period. The second application will be applied when the cervical dilatation is 5-7 cm and the third application will be applied when the cervical dilatation is 8-10 cm. 'Visual Analog Scale (VAS)' will be applied after each application. 'Visual Analog Scale (VAS)', 'Beck Anxiety Scale (BAS)' and 'Oxford Birth Anxiety Scale (OWLS)' will be applied at the 2nd hour after delivery.
- Conditions
- Labor Pain, Anxiety
- Being tested
- Experimental group
- Keywords
- Anxiety, Alexander Technique, Midwifery, Labor Pain
- Medical subject headings
- Labor Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupOther
Alexander technique will be applied to the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The application of the Alexander Technique to the women included in the experimental group will be created by providing body awareness by directing their current posture and movements in line with three principles. In this way, self-management of the birth process in primiparous women will be established. In order to develop the body awareness of the primiparous woman, the Alexander Technique will be applied with the training program created by the researcher in line with the three principles. Receives: Other: Experimental group |
| Conventional group | Other | The conventional (control group) will receive routine midwifery care during the birth process. Routine midwifery care includes follow-up of the pregnant woman and the baby and uninterrupted midwife support during the birth process. Receives: Other: Experimental group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreasing labor pain
Alexander Technique applied in labor pain management has a decreasing effect on labor pain.
Measured: During labor, the first assessment will be performed when cervical dilatation is 0-4 cm, the second assessment when cervical dilatation is 5-7 cm and the third assessment when cervical dilatation is 8-10 cm.
Decreasing anxiety
The Alexander Technique applied in labor pain management has a reducing effect on anxiety during labor.
Measured: During labor, the first assessment will be performed when cervical dilatation is 0-4 cm, the second assessment when cervical dilatation is 5-7 cm and the third assessment when cervical dilatation is 8-10 cm.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start5 Feb 2024
- Primary completion1 Jun 2024 (estimated)
- Study completion2 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Marmara UniversityThe 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
- Model description
- One experimental group and one conventional (control) group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263894
- Sponsor's protocol ID
- MarmaraU-Ebe-ZDY-01
- Status last verified
- Feb 2024
- First submitted
- 9 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hanefeld N, Glover L, Jomeen J, Wadephul F. Women's experiences of using the Alexander Technique in the postpartum: '...in a way, it's just as beneficial as sleep'. Midwifery. 2021 Dec;103:103155. doi: 10.1016/j.midw.2021.103155. Epub 2021 Oct 1.
PubMed 34655836Kinsey, D., Glover, L., & Wadephul, F. (2021). How does the Alexander Technique lead to psychological and non-physical outcomes? A realist review. European Journal of Integrative Medicine, 46, 101371.
Klein SD, Bayard C, Wolf U. The Alexander Technique and musicians: a systematic review of controlled trials. BMC Complement Altern Med. 2014 Oct 24;14:414. doi: 10.1186/1472-6882-14-414.
PubMed 25344325
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 the Alexander Technique on Labor Pain and Anxiety: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06263894
- Acronym / sponsor ID
- MarmaraU-Ebe-ZDY-01
- Conditions
- Labor Pain, Anxiety
- Keywords
- Anxiety, Alexander Technique, Midwifery, Labor Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 2 Jul 2024 (estimated)
- First posted
- 16 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.
This study will examine the effect of the Alexander Technique on labor pain and anxiety during labor. This study is designed as a randomized controlled experimental study. The population of the study consists of primiparous pregnant women who applied to Istanbul Provincial Health Directorate Başakşehir Çam and Sakura City Hospital, D-Block Maternity Hospital between November 2023 and May 2024. In calculating the sample size, G*Power (3.1.9.6) program was used to calculate the sample size with an error of 0.05, effect level of 0.5, power of 95%, and the required sample size for 2 groups was calculated as 34 people for each group with a total of 68 people.
Detailed description
Pain during childbirth has been described as the most severe pain women experience throughout their life course. Labor pain is a result of physiologic changes in the uterus. Pharmacologic and nonpharmacologic methods are used in the management of pain, which is a physiologic process. Nonpharmacological methods help women to feel comfortable in labor and contribute to women to have a positive birth experience by providing relaxation and reducing pain perception through cognitive, psychological and physical methods (Adil et al., 2020; Thompson et al. 2019). In addition, midwives who are with the woman during the birth process use non-pharmacological methods in an independent role in the management of labor pain, and this is also effective in alleviating the burden on current health expenditures. Alexander Technique appears as a non-pharmacologic method. In the literature, there is no study on the application of the Alexander Technique in the management of labor pain. It is assumed that the current posture and position to be provided with the Alexander Technique will be effective on pain and anxiety during the birth process. It is necessary to conduct studies on the use of the Alexander Technique in the birth process and evaluate the results.
This study will be the first study on the Alexander Technique to be applied to women in labor. The research to be conducted is planned as a randomized controlled experimental study. The population of the study consists of 68 primiparous pregnant women who applied to Istanbul Provincial Health Directorate Başakşehir Çam and Sakura City Hospital, D-Block Maternity Hospital between November 2023 and May 2024. Simple random sampling method will be used for the sample of the study. Pregnant women included in the study will be informed about the study and 'Informed Consent Form' and 'Voluntary Consent Form' will be filled. 'Personal Information Form', 'Visual Analog Scale (VAS)', 'Beck Anxiety Scale (BAS)' and 'Oxford Birth Anxiety Scale (OWLS)' will be applied to the pregnant women included in the experimental group. After the initial data is collected, the principles in the Alexander Technique will be applied when the woman's cervical dilatation is 0-4 cm. The duration of the application is approximately 15 minutes and the researcher will take an active role with the woman accompanied by a counselor during this period. The second application will be applied when the cervical dilatation is 5-7 cm and the third application will be applied when the cervical dilatation is 8-10 cm. 'Visual Analog Scale (VAS)' will be applied after each application. 'Visual Analog Scale (VAS)', 'Beck Anxiety Scale (BAS)' and 'Oxford Birth Anxiety Scale (OWLS)' will be applied at the 2nd hour after delivery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- One experimental group and one conventional (control) group
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Experimental groupThe application of the Alexander Technique to the women included in the experimental group will be created by providing body awareness by directing their current posture and movements in line with three principles. In this way, self-management of the birth process in primiparous women will be established. In order to develop the body awareness of the primiparous woman, the Alexander Technique will be applied with the training program created by the researcher in line with the three principles. |
| Conventional group | Other | Other: Experimental groupThe conventional (control group) will receive routine midwifery care during the birth process. Routine midwifery care includes follow-up of the pregnant woman and the baby and uninterrupted midwife support during the birth process. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Volunteer to participate in the study,
- Between the ages of 18-35,
- Primiparous and singleton pregnant,
- Women at term (between 37 and 41 weeks of gestation) will be included in the study.
Key exclusion criteria (5 listed)
- Risky pregnancies,
- Women who become pregnant as a result of assisted reproductive techniques,
- Delivery by caesarean section,
- Wanting to leave without working,
- Women undergoing analgesia at any stage of the labor process will be excluded from the study.
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 |
|---|---|---|
| Experimental groupAlexander technique will be applied to the experimental group. | Other | Conventional group, Experimental group |
Primary outcome
Decreasing labor pain
Time frame: During labor, the first assessment will be performed when cervical dilatation is 0-4 cm, the second assessment when cervical dilatation is 5-7 cm and the third assessment when cervical dilatation is 8-10 cm.
Alexander Technique applied in labor pain management has a decreasing effect on labor pain.
Decreasing anxiety
Time frame: During labor, the first assessment will be performed when cervical dilatation is 0-4 cm, the second assessment when cervical dilatation is 5-7 cm and the third assessment when cervical dilatation is 8-10 cm.
The Alexander Technique applied in labor pain management has a reducing effect on anxiety during labor.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Background: PubMed 34655836Hanefeld N, Glover L, Jomeen J, Wadephul F. Women's experiences of using the Alexander Technique in the postpartum: '...in a way, it's just as beneficial as sleep'. Midwifery. 2021 Dec;103:103155. doi: 10.1016/j.midw.2021.103155. Epub 2021 Oct 1.
- Results publicationKinsey, D., Glover, L., & Wadephul, F. (2021). How does the Alexander Technique lead to psychological and non-physical outcomes? A realist review. European Journal of Integrative Medicine, 46, 101371.
- Results publication: PubMed 25344325Klein SD, Bayard C, Wolf U. The Alexander Technique and musicians: a systematic review of controlled trials. BMC Complement Altern Med. 2014 Oct 24;14:414. doi: 10.1186/1472-6882-14-414.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Labor Pain and Anxiety, run by Marmara 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 4 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: status not confirmed, 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decreasing labor pain (time frame: During labor, the first assessment will be performed when cervical dilatation is 0-4 cm, the second assessment when cervical dilatation is 5-7 cm and the third assessment when cervical dilatation is 8-10 cm.). 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 NCT06263894, which also lists 3 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.