NCT06263894

Brief 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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

4 months

First QC Date

February 9, 2024

Last Update Submit

February 16, 2024

Conditions

Keywords

AnxietyAlexander TechniqueMidwiferyLabor Pain

Outcome Measures

Primary Outcomes (2)

  • Decreasing labor pain

    Alexander Technique applied in labor pain management has a decreasing effect on labor pain.

    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.

    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.

Study Arms (2)

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.

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.

Other: Experimental group

Interventions

Alexander technique will be applied to the experimental group.

Conventional groupExperimental group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Başakşehir Çam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • 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.

    PMID: 34655836BACKGROUND
  • Kinsey, 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.

    RESULT
  • 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.

MeSH Terms

Conditions

Labor PainAnxiety Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
In order to reduce selection bias in determining the experimental and control groups, a computer-assisted randomization program (https://www.randomizer.org) will be used for pregnant women who meet the inclusion criteria.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: One experimental group and one conventional (control) group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2024

First Posted

February 16, 2024

Study Start

February 5, 2024

Primary Completion

June 1, 2024

Study Completion

July 2, 2024

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations