NCT06813547

Brief Summary

Fear of labour in primiparous pregnant women is an important factor that directly affects the mother-infant relationship and the mental health of the mother. In this process, it is common for expectant mothers to experience feelings of uncertainty and anxiety about labour. Such intense fear of birth may weaken maternal attachment and make it difficult for her to establish a healthy emotional relationship with her baby. In addition, this fear may negatively affect the mother's mental well-being and increase the risk of depression and anxiety. In this context, emotional liberation techniques (EFT) and virtual reality (VR) applications stand out as effective nonpharmacological methods used to reduce fear of childbirth in primiparous pregnant women. EFT is a technique that provides relaxation by touching the energy meridians that help the person to regulate negative emotions and cope with stress. SG, on the other hand, allows expectant mothers to interact with simulations similar to the real world in a virtual environment, providing therapeutic benefits through distraction, stress reduction and cognitive restructuring, allowing them to manage their fears about birth and enter the process more prepared. The use of SLT and SG, especially for primiparous pregnant women, can alleviate these women's anxiety about childbirth and enable them to approach the process in a safer and more conscious manner. Thus, it may also help to reduce the negative effects on the mother's postnatal attachment and mental health. This study aims to examine the effects of SLT and SG practices on fear of childbirth, attachment and mental well-being, and to reveal the effects of these two methods on primiparous pregnant women. In this context, this study will fill the gap in the literature by providing a new perspective in clinical practice and antenatal education programmes and will make important contributions to increase antenatal attachment and mental well-being in primiparous pregnancy.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Jan 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jan 2025May 2026

First Submitted

Initial submission to the registry

December 12, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

January 31, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 7, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Expected
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

11 months

First QC Date

December 12, 2024

Last Update Submit

May 24, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Wijma Birth Anticipation/Fear Scale - Version A

    The level of fear of labour will be assessed using a validated instrument, the Wijma Birth Anticipation/Fear Scale (Version A). Scores range from 0 to 165, with higher scores indicating higher levels of fear of labour.

    32-38 weeks of gestation

  • Warwick-Edinburgh Mental Well-Being Scale - WEMWBS

    Mental well-being will be measured using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS). Scores range from 14 to 70, with higher scores indicating higher mental well-being

    32-38 weeks of gestation

  • Prenatal Mother-Infant Attachment Prenatal Mother-Infant Attachment Prenatal Mother-Infant Attachment

    Maternal attachment to the unborn baby will be evaluated using the Prenatal Maternal Attachment Scale. Scores range from 21 to 84, with higher scores indicating stronger maternal attachment.

    32-38 weeks of gestation

  • Subjective Unit Experience Scale

    The scale, which was developed by Hartmann is utilised in EFT applications and enables the individual to categorise their own emotions by evaluating them with numbers. The SUE, a specific EFT instrument, is utilised to ascertain the intensity (degree) of the emotion experienced at the commencement and conclusion of the session. The scale is scored between -10 and +10, with negative numbers denoting negative/unpleasant experiences and positive numbers denoting positive/pleasant experiences.

    32-38 weeks of gestation

Secondary Outcomes (1)

  • Demographic Characteristics of Participants

    32-38 weeks of gestation

Study Arms (3)

Emotional freedom techniques group

EXPERIMENTAL

Emotional Freedom Techniques (EFT) application group; Participants will receive EFT intervention once a week for four weeks, with pre- and post-assessment using scales and subjective experience units.

Behavioral: emotional freedom techniques

Emotional freedom techniques + virtual reality group

EXPERIMENTAL

Emotional Freedom Techniques (EFT) and Virtual Reality (VR) application group; Participants will receive both EFT and VR interventions once a week for four weeks, with pre- and post-assessment using scales and subjective experience units.

Behavioral: emotional freedom techniques and virtual reality

Control group

OTHER

Control group; Participants will receive standard antenatal care with pre- and post-assessment using scales and subjective experience units, but no EFT or VR intervention.

Behavioral: control group/ none intervention

Interventions

emotional freedom techniques

Emotional freedom techniques group

emotional freedom techniques and virtual reality

Emotional freedom techniques + virtual reality group

None intervention

Control group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • No verbal communication problems
  • Primiparous pregnancy
  • /0-38/0 weeks of gestation
  • Having a single, viable foetus
  • No psychiatric disorder
  • No obstetric complications
  • Absence of scar tissue or an obstacle to touch at the points of EFT application

You may not qualify if:

  • Not wanting to continue the research
  • Early labour

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malatya Training and Research Hospital

Malatya, Turkey (Türkiye)

RECRUITING

Related Publications (10)

  • Hajesmaeel-Gohari S, Sarpourian F, Shafiei E. Virtual reality applications to assist pregnant women: a scoping review. BMC Pregnancy Childbirth. 2021 Mar 25;21(1):249. doi: 10.1186/s12884-021-03725-5.

    PMID: 33765969BACKGROUND
  • Koo CH, Park JW, Ryu JH, Han SH. The Effect of Virtual Reality on Preoperative Anxiety: A Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2020 Sep 29;9(10):3151. doi: 10.3390/jcm9103151.

    PMID: 33003411BACKGROUND
  • Freitas JRS, Velosa VHS, Abreu LTN, Jardim RL, Santos JAV, Peres B, Campos PF. Virtual Reality Exposure Treatment in Phobias: a Systematic Review. Psychiatr Q. 2021 Dec;92(4):1685-1710. doi: 10.1007/s11126-021-09935-6. Epub 2021 Jun 26.

    PMID: 34173160BACKGROUND
  • Guven Santur S, Ozsahin Z. The Effects of Emotional Freedom Techniques Implemented During Early Pregnancy on Nausea-Vomiting Severity and Anxiety: A Randomized Controlled Trial. J Integr Complement Med. 2024 Sep;30(9):858-868. doi: 10.1089/jicm.2023.0586. Epub 2024 Mar 27.

    PMID: 38531058BACKGROUND
  • Maples-Keller JL, Yasinski C, Manjin N, Rothbaum BO. Virtual Reality-Enhanced Extinction of Phobias and Post-Traumatic Stress. Neurotherapeutics. 2017 Jul;14(3):554-563. doi: 10.1007/s13311-017-0534-y.

    PMID: 28512692BACKGROUND
  • Bilgic G, Citak Bilgin N. Relationship Between Fear of Childbirth and Psychological and Spiritual Well-Being in Pregnant Women. J Relig Health. 2021 Feb;60(1):295-310. doi: 10.1007/s10943-020-01087-4. Epub 2020 Sep 19.

    PMID: 32949330BACKGROUND
  • Aguilera-Martin A, Galvez-Lara M, Blanco-Ruiz M, Garcia-Torres F. Psychological, educational, and alternative interventions for reducing fear of childbirth in pregnant women: A systematic review. J Clin Psychol. 2021 Mar;77(3):525-555. doi: 10.1002/jclp.23071. Epub 2020 Oct 20.

    PMID: 33078851BACKGROUND
  • Anderson CA, Gill M. Childbirth related fears and psychological birth trauma in younger and older age adolescents. Appl Nurs Res. 2014 Nov;27(4):242-8. doi: 10.1016/j.apnr.2014.02.008. Epub 2014 Feb 27.

    PMID: 24726421BACKGROUND
  • Moller L, Josefsson A, Lilliecreutz C, Gunnervik C, Bladh M, Sydsjo G. Reproduction, fear of childbirth and obstetric outcomes in women treated for fear of childbirth in their first pregnancy: A historical cohort. Acta Obstet Gynecol Scand. 2019 Mar;98(3):374-381. doi: 10.1111/aogs.13503. Epub 2018 Dec 3.

    PMID: 30431149BACKGROUND
  • Deliktas A, Kukulu K. Pregnant Women in Turkey Experience Severe Fear of Childbirth: A Systematic Review and Meta-Analysis. J Transcult Nurs. 2019 Sep;30(5):501-511. doi: 10.1177/1043659618823905. Epub 2019 Jan 17.

    PMID: 30651038BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Zeliha Özşahin, Dr

    Inonu University

    STUDY DIRECTOR

Central Study Contacts

Sinem Güven Santur, Msc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Res. Assist.

Study Record Dates

First Submitted

December 12, 2024

First Posted

February 7, 2025

Study Start

January 31, 2025

Primary Completion

December 31, 2025

Study Completion (Estimated)

May 30, 2026

Last Updated

May 30, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Even if the participants voluntarily agree to participate in the research in the country we live in, I cannot make this sharing because it is not legal to share the individual data of the participants.

Locations