Paternal Childbirth FearNCT07704541
Effect of Mandala Art Therapy on Childbirth Fear and Anxiety in Expectant Fathers
A study testing Mandala Art Therapy in people with Paternal Childbirth Fear and State Anxiety, run by Inonu University.
Trial summary
This randomized controlled trial is designed to evaluate the effectiveness of mandala art therapy in reducing childbirth fear and state anxiety among fathers whose partners are nulliparous pregnant women and who are waiting in the obstetric ward waiting area during labor. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Paternal Childbirth Fear, State Anxiety, Psychological Distress
- What is being tested?
- Mandala Art Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Nov 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 18 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Fathers whose partners are nulliparous pregnant women Fathers aged 18 years and older Fathers whose partners are admitted for planned vaginal delivery Fathers present in the obstetric waiting area during the study period Fathers who are able to read and understand Turkish Fathers who voluntarily agree to participate in the study
Who cannot join
- Presence of obstetric emergency or unplanned change in delivery method (e.g., emergency cesarean section) History of diagnosed psychiatric disorders requiring treatment (e.g., anxiety disorders) Inability to understand or complete study questionnaires Absence from the waiting area during the intervention period
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Mandala Art Therapy on Fear and Anxiety of Childbirth in Expectant Fathers Waiting Outside the Delivery Room: A Randomized Controlled Study
This randomized controlled trial is designed to evaluate the effectiveness of mandala art therapy in reducing childbirth fear and state anxiety among fathers whose partners are nulliparous pregnant women and who are waiting in the obstetric ward waiting area during labor. Eligible participants will be randomly allocated to either the intervention or the control group. Fathers assigned to the intervention group will participate in a single 20-25-minute mandala art therapy session, whereas those in the control group will receive standard care without any additional intervention. Childbirth fear and state anxiety will be assessed using the Fathers' Birth Fear Scale and the State subscale of the Spielberger State-Trait Anxiety Inventory, respectively, at baseline and immediately following the intervention. The findings of this study are expected to provide evidence regarding the effectiveness of mandala art therapy as a non-pharmacological intervention for alleviating childbirth-related fear and anxiety among expectant fathers.
Read the detailed description
This study is a randomized controlled trial designed to evaluate the effectiveness of mandala art therapy in reducing childbirth fear and state anxiety among expectant fathers whose partners are nulliparous pregnant women and who are waiting in the obstetric ward waiting area during labor. Eligible participants will be randomly allocated to either the intervention or the control group using a simple randomization procedure. Participants assigned to the intervention group will receive a single, individually administered mandala art therapy session lasting approximately 20-25 minutes. During the session, participants will be encouraged to select their preferred mandala patterns and colors, thereby facilitating individual expression and engagement in the therapeutic process. Participants in the control group will receive routine care without any additional intervention and will undergo the same assessment procedures as the intervention group. Data will be collected at two time points: immediately before the intervention (baseline) and immediately after the intervention. The primary outcome of the study is childbirth fear, while the secondary outcome is state anxiety.
- Being tested
- Mandala Art Therapy
- Keywords
- mandala art therapy, childbirth fear, obstetric waiting room
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala Art TherapyBehavioural
Participants will engage in a mandala coloring activity lasting approximately 20-25 minutes. The intervention is designed as a relaxation-based expressive art therapy. Participants will select mandala patterns and colors freely. No guidance or psychological counseling is provided during the activity.
| Study group | Role | What they receive |
|---|---|---|
| Mandala Art Therapy Group | Experimental | Participants in this group will receive mandala art therapy. The intervention consists of a 20-25 minute individual mandala coloring activity conducted in the obstetric waiting area. Participants will be provided with a mandala coloring book and colored pencils and will freely choose patterns and colors. Receives: Behavioral: Mandala Art Therapy |
| Control Group | No intervention | Participants in this group will receive no intervention. They will complete the same pre-test and post-test assessments as the intervention group at the same time points. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Childbirth Fear
Childbirth fear will be assessed using the Fathers' Birth Fear Scale (BDKÖ). The scale measures fathers' fear related to childbirth process and hospital-related concerns. Higher scores indicate higher levels of childbirth fear. Assessments will be performed before and after the mandala art therapy intervention.
Measured: Baseline and immediately after intervention (approximately 30-45 minutes post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paternal Childbirth FearStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Participants will be randomly allocated to two parallel groups: an intervention group receiving mandala art therapy and a control group receiving no intervention. Outcome assessments will be performed at baseline, prior to the intervention, and repeated immediately following the intervention.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Melike TAN ÇELİK, Inonu University
- Investigators
- Esra GÜNEY, Associate Professor, Study director, İnönü University Faculty of Health SciencesMelike Tan, midwife, Study director, İnönü University Faculty of Health SciencesZeynep Bal, PhD, Principal investigator, Turgut Özal University Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704541
- Sponsor's protocol ID
- 10843
- Status last verified
- Jul 2026
- First submitted
- 13 Jun 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, individual participant data will not be shared.
Publications
Hildingsson I, Johansson M, Fenwick J, Haines H, Rubertsson C. Childbirth fear in expectant fathers: findings from a regional Swedish cohort study. Midwifery. 2014 Feb;30(2):242-7. doi: 10.1016/j.midw.2013.01.001. Epub 2013 Feb 27.
PubMed 23455031
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala Art Therapy on Fear and Anxiety of Childbirth in Expectant Fathers Waiting Outside the Delivery Room: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07704541
- Acronym / sponsor ID
- 10843
- Keywords
- mandala art therapy, childbirth fear, obstetric waiting room
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 15 Jul 2026 (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 randomized controlled trial is designed to evaluate the effectiveness of mandala art therapy in reducing childbirth fear and state anxiety among fathers whose partners are nulliparous pregnant women and who are waiting in the obstetric ward waiting area during labor. Eligible participants will be randomly allocated to either the intervention or the control group. Fathers assigned to the intervention group will participate in a single 20-25-minute mandala art therapy session, whereas those in the control group will receive standard care without any additional intervention. Childbirth fear and state anxiety will be assessed using the Fathers' Birth Fear Scale and the State subscale of the Spielberger State-Trait Anxiety Inventory, respectively, at baseline and immediately following the intervention. The findings of this study are expected to provide evidence regarding the effectiveness of mandala art therapy as a non-pharmacological intervention for alleviating childbirth-related fear and anxiety among expectant fathers.
Detailed description
This study is a randomized controlled trial designed to evaluate the effectiveness of mandala art therapy in reducing childbirth fear and state anxiety among expectant fathers whose partners are nulliparous pregnant women and who are waiting in the obstetric ward waiting area during labor. Eligible participants will be randomly allocated to either the intervention or the control group using a simple randomization procedure. Participants assigned to the intervention group will receive a single, individually administered mandala art therapy session lasting approximately 20-25 minutes. During the session, participants will be encouraged to select their preferred mandala patterns and colors, thereby facilitating individual expression and engagement in the therapeutic process. Participants in the control group will receive routine care without any additional intervention and will undergo the same assessment procedures as the intervention group. Data will be collected at two time points: immediately before the intervention (baseline) and immediately after the intervention. The primary outcome of the study is childbirth fear, while the secondary outcome is state anxiety.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated to two parallel groups: an intervention group receiving mandala art therapy and a control group receiving no intervention. Outcome assessments will be performed at baseline, prior to the intervention, and repeated immediately following the intervention.
| Arm | Type | Receives |
|---|---|---|
| Mandala Art Therapy Group | Experimental | Behavioral: Mandala Art TherapyParticipants in this group will receive mandala art therapy. The intervention consists of a 20-25 minute individual mandala coloring activity conducted in the obstetric waiting area. Participants will be provided with a mandala coloring book and colored pencils and will freely choose patterns and colors. |
| Control Group | No intervention | –Participants in this group will receive no intervention. They will complete the same pre-test and post-test assessments as the intervention group at the same time points. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Fathers whose partners are nulliparous pregnant women Fathers aged 18 years and older Fathers whose partners are admitted for planned vaginal delivery Fathers present in the obstetric waiting area during the study period Fathers who are able to read and understand Turkish Fathers who voluntarily agree to participate in the study
Key exclusion criteria (1 listed)
- Presence of obstetric emergency or unplanned change in delivery method (e.g., emergency cesarean section) History of diagnosed psychiatric disorders requiring treatment (e.g., anxiety disorders) Inability to understand or complete study questionnaires Absence from the waiting area during the intervention period
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 |
|---|---|---|
| Mandala Art TherapyParticipants will engage in a mandala coloring activity lasting approximately 20-25 minutes. The intervention is designed as a relaxation-based expressive art therapy. Participants will select mandala patterns and colors freely. No guidance or psychological counseling is provided during the activity. | Behavioural | Mandala Art Therapy Group |
Primary outcome
Childbirth Fear
Time frame: Baseline and immediately after intervention (approximately 30-45 minutes post-intervention)
Childbirth fear will be assessed using the Fathers' Birth Fear Scale (BDKÖ). The scale measures fathers' fear related to childbirth process and hospital-related concerns. Higher scores indicate higher levels of childbirth fear. Assessments will be performed before and after the mandala art therapy intervention.
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 20 Jul 2026.
- Results publication: PubMed 23455031Hildingsson I, Johansson M, Fenwick J, Haines H, Rubertsson C. Childbirth fear in expectant fathers: findings from a regional Swedish cohort study. Midwifery. 2014 Feb;30(2):242-7. doi: 10.1016/j.midw.2013.01.001. Epub 2013 Feb 27.
- Fathers' fear of childbirthLink provided by the sponsor.
- Individual participant dataSharing planned: No. No, individual participant data will not be shared.
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.
Esra GÜNEY, Associate Professor study director
İnönü University Faculty of Health Sciences
Melike Tan, midwife study director
İnönü University Faculty of Health Sciences
Zeynep Bal, PhD principal investigator
Turgut Özal University Faculty of Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Mandala Art Therapy in people with Paternal Childbirth Fear and State Anxiety, run by Inonu University.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 ESRA GÜNEY, Associate Professor (+90 5432064063, esra.guney@inonu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childbirth Fear (time frame: Baseline and immediately after intervention (approximately 30-45 minutes post-intervention)). 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 NCT07704541, which also lists 1 linked publication.
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 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.