- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06813547
Emotional Freedom Techniques and Virtual Reality Application for Fear of Childbirth
The Effect of Emotional Freedom Techniques and Virtual Reality Application Applied to Reduce the Fear of Childbirth on Attachment and Mental Well-being in Primiparous Pregnant Women
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sinem Güven Santur, Msc
- Phone Number: 00905424640068
- Email: ysinemguven@gmail.com
Study Locations
-
-
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Malatya, Turkey
- Recruiting
- Malatya Training and Research Hospital
-
Contact:
- Central Campus
- Email: malatyaeah@saglik.gov.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- No verbal communication problems
- Primiparous pregnancy
- 32/0-38/0 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
Exclusion Criteria:
- Not wanting to continue the research
- Early labour
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Emotional freedom techniques group
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.
|
emotional freedom techniques
|
|
Experimental: Emotional freedom techniques + virtual reality group
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.
|
emotional freedom techniques and virtual reality
|
|
Other: Control group
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.
|
None intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wijma Birth Anticipation/Fear Scale - Version A
Time Frame: 32-38 weeks of gestation
|
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
Time Frame: 32-38 weeks of gestation
|
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
Time Frame: 32-38 weeks of gestation
|
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
Time Frame: 32-38 weeks of gestation
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demographic Characteristics of Participants
Time Frame: 32-38 weeks of gestation
|
Age, education level, marital status, socioeconomic status, gestational week, and previous pregnancy history will be collected using a demographic information form. Group Comparability After Randomization Baseline demographic and clinical characteristics will be analyzed to ensure balance across groups after randomization. Subgroup Analysis Based on Age and Education Level Intervention effects will be examined across subgroups categorized by age and education level. Duration of Fear of Childbirth The duration of childbirth fear (in weeks or months) will be self-reported by participants. Previous Psychological Support History Participants' history of psychological support will be recorded via self-reported questionnaires. |
32-38 weeks of gestation
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Zeliha Özşahin, Dr, Inonu University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Institute of Health Sciences
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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