Fear of ChildbirthNCT06813547
Emotional Freedom Techniques and Virtual Reality Application for Fear of Childbirth
A study testing emotional freedom techniques and emotional freedom techniques and virtual reality in people with Fear of Childbirth and Mental Well-being, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fear of Childbirth, Mental Well-being, Attachment
- What is being tested?
- emotional freedom techniques and emotional freedom techniques and virtual reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jan 2025to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not wanting to continue the research
- Early labour
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Malatya Training and Research Hospital
Malatya
Central Campus, malatyaeah@saglik.gov.tr
About this study
Official title: 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.
- Conditions
- Fear of Childbirth, Mental Well-being, Attachment, Emotional Freedom Technique, Virtual Reality, Primiparous Pregnant Women
- Being tested
- emotional freedom techniques, emotional freedom techniques and virtual reality, control group/ none intervention
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emotional freedom techniquesBehavioural
emotional freedom techniques
emotional freedom techniques and virtual realityBehavioural
emotional freedom techniques and virtual reality
control group/ none interventionBehavioural
None intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: control group/ none intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 32-38 weeks of gestation
Secondary outcomes (1)
Demographic Characteristics of Participants
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.
Measured: 32-38 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start31 Jan 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Fear of ChildbirthStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinem GUVEN Santur, Inonu University
- Investigators
- Zeliha Özşahin, Dr, Study director, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813547
- Sponsor's protocol ID
- Institute of Health Sciences
- Status last verified
- May 2025
- First submitted
- 12 Dec 2024
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 33765969Koo 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.
PubMed 33003411Freitas 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.
PubMed 34173160Guven 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.
PubMed 38531058Maples-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.
PubMed 28512692Bilgic 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.
PubMed 32949330Aguilera-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.
PubMed 33078851Anderson 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.
PubMed 24726421Moller 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.
PubMed 30431149Deliktas 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.
PubMed 30651038
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06813547
- Acronym / sponsor ID
- Institute of Health Sciences
- Conditions
- Fear of Childbirth, Mental Well-being, Attachment, Emotional Freedom Technique, Virtual Reality, Primiparous Pregnant Women
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 7 Feb 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Emotional freedom techniques group | Experimental | Behavioral: emotional freedom techniquesEmotional 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 + virtual reality group | Experimental | Behavioral: emotional freedom techniques and virtual realityEmotional 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. |
| Control group | Other | Behavioral: control group/ none interventionControl group; Participants will receive standard antenatal care with pre- and post-assessment using scales and subjective experience units, but no EFT or VR intervention. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- No verbal communication problems
- Primiparous pregnancy
- 32/0-38/0 weeks of gestation
- Having a single, viable foetus
- No psychiatric disorder
Key exclusion criteria (2 listed)
- Not wanting to continue the research
- Early labour
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 |
|---|---|---|
| emotional freedom techniquesemotional freedom techniques | Behavioural | Emotional freedom techniques group |
| emotional freedom techniques and virtual realityemotional freedom techniques and virtual reality | Behavioural | Emotional freedom techniques + virtual reality group |
| control group/ none interventionNone intervention | Behavioural | Control group |
Primary outcome
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.
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
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.
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.
1 secondary outcome
Demographic Characteristics of Participants
Time frame: 32-38 weeks of gestation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Results publication: PubMed 33765969Hajesmaeel-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.
- Results publication: PubMed 33003411Koo 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.
- Results publication: PubMed 34173160Freitas 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.
- Results publication: PubMed 38531058Guven 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.
- Results publication: PubMed 28512692Maples-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.
- Results publication: PubMed 32949330Bilgic 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.
- Results publication: PubMed 33078851Aguilera-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.
- Results publication: PubMed 24726421Anderson 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.
- Results publication: PubMed 30431149Moller 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.
- Results publication: PubMed 30651038Deliktas 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.
- Individual participant dataSharing planned: No. 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.
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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.
Zeliha Özşahin, Dr study director
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing emotional freedom techniques and emotional freedom techniques and virtual reality in people with Fear of Childbirth and Mental Well-being, run by Inonu 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 7 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: looking for participants now, as of the sponsor's last update on 30 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sinem Güven Santur, Msc (00905424640068, ysinemguven@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wijma Birth Anticipation/Fear Scale - Version A (time frame: 32-38 weeks of gestation). The study lists 4 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 NCT06813547, which also lists 10 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 30 May 2025.