Fear of ChildbirthNCT06257186
Investigating the Effect of Art Therapy on Women With Fear of Childbirth During Pregnancy: A Mixed Method Study
A study testing Art Therapy in people with Fear of Childbirth and Pregnancy Related, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
Childbirth is a multifaceted experience and could involve both positive and negative feelings. Feelings of limited capability in the face of childbirth may result in a condition termed as Fear of Childbirth (FOC), which contributes to significantly higher risks of birth complications resulting in psychological trauma. Read more about this study
- Who is it for?
- Ages 21 to 50 years, women only
- Conditions the study is for
- Fear of Childbirth, Pregnancy Related, Anxiety and Fear
- What is being tested?
- Art Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- 2 Nov 2023to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 21 and 50 years old
- English literate
- Having an intrauterine singleton live pregnancy
- Currently in the second trimester of the pregnancy (between 13 to 27 weeks of pregnancy)
- Fear of Birth Scale (FOBS) score of 60 and above
Who cannot join
- With contraindication for vaginal birth (for example placenta covering cervix)
- With obstetric complications during pregnancy such as fetal anomaly that is incompatible with life
- With current depression requiring medical intervention
- Who had stillborn delivery
- Phase II Inclusion Criteria Enrolled participants who had undergone the Art Therapy intervention in phase one
Trial locations and contacts
1 site in 1 country.
Sujitha L Kumar, BE(BioEng) contact
Singapore1 site, 1 recruiting
- Recruiting
KK Women's and Children's Hospital
Singapore
Mei Qi Ang, MSc(Nursing), 6530 3125, ang.mei.qi@kkh.com
Sujitha L Kumar, BE(BioEng), sujitha.lakshmana.kumar@kkh.com.sg
About this study
Childbirth is a multifaceted experience and could involve both positive and negative feelings. Feelings of limited capability in the face of childbirth may result in a condition termed as Fear of Childbirth (FOC), which contributes to significantly higher risks of birth complications resulting in psychological trauma. This study aims to examine the effects of Art Therapy (AT) on FOC, perceived maternal parental self-efficacy, postpartum maternal infant bonding and postpartum depression.
A mixed-methods sequential explanatory design will be used. Phase one will adopt a quasi-experimental study design. Women who are aged 21 and above, English literate and having a singleton pregnancy will be approached to fill in the Fear of Birth Scale (FOBS). Participants with FOBS score of 60 and above will be considered as having FOC and will be invited to participate in the AT intervention. Participants who are agreeable to receive AT will be recruited in the experimental group. Participants who declined to participate in AT will receive routine antenatal care (control group). Outcomes that will be measured in both groups include perceived maternal self-efficacy, maternal infant bonding, and maternal depression after childbirth. A qualitative descriptive design will be used in phase two. Semi-structured interviews will be conducted with the participants to explore their experiences of the AT. Descriptive analysis, independent sample t-test, paired sample t-test, and regression analysis will be used for analysis of the quantitative data in phase one. Qualitative data from phase two will be analysed using thematic analysis.
Findings of this study may provide evidence on the use of AT to cope with FOC during pregnancy. If proven to be beneficial, AT may potentially be introduced and advocated as an intervention for women with FOC.
Read the detailed description
Research Design:
A mixed-methods sequential explanatory design will be used. Phase one will be quasi-experimental study design, comparing women with FOC who received art therapy (experimental group) and women who received routine antenatal care (control group). A qualitative descriptive design will be used in phase two to explore the experiences of the participants who had art therapy for FOC.
Sampling:
Convenience sampling will be used for phase one. Purposive sampling will be used for phase two, for which only participants who had undergone the art therapy intervention will be invited to participate.
Consented participants will be invited to fill in the Fear of Birth Scale (FOBS). Participants with FOBS score of 60 and above will be enrolled into the study. Participants will be invited to participate in the Art Therapy intervention (experimental group). If participants are not agreeable to participate in the art therapy, they will be allocated to the control group.
Participants who had undergone the Art Therapy intervention will be invited to participate in phase two.
Sample Size:
Phase One: The study team is targeting to recruit 1200 participants to screen for FOC in phase one. Participants with FOC will be invited to continue participation in the quasi-experimental study with a target allocation of 1:1 in each group.
Phase Two: The sample size will be determined by data saturation, whereby no new information is identified from the data. This is estimated to be about sample size of 30 participants.
Data Collection Procedures:
Phase One:
Potential participants who are in the second trimester of their pregnancy (between 13 and 27 weeks of gestation) will be approached in the antenatal clinics. Details of the study will be explained using the Participant Information Sheet (PIS). After which, the FOBS will be used to measure the FOC. Recruited participants will be asked to fill in a hardcopy questionnaire.
After the participant has completed the questionnaire, the FOBS score will be tabulated and participants with FOBS score of more than or equal to 60 will be invited to participate in the intervention, which is a series of three to five art therapy sessions, depending on the participants' needs/preferences.
Women who are willing to participate in the art therapy sessions will be included in the experimental group, while women who received routine antenatal care but are not agreeable to participate in the art therapy sessions will be included in the control group. A study team member will contact the participants to arrange for the art therapy sessions and administration of the questionnaires.
A set of art materials will be provided to participants to use throughout the art therapy sessions, and to encourage participants to continue artmaking for self-care outside of sessions. The first session will be in a face-to-face format at a date and time agreed by the participant. Subsequent sessions will be offered via telehealth on dates and times agreed by the participant. Each session will last between 60 to 90 minutes and will be facilitated by an Art Therapist. Each session will be structured around themes aimed at building self-awareness, encouraging expressions of difficult emotions, strengthening the bond between participants and their child, and to facilitate the verbal counselling within the safety of art therapy session. FOBS score will be obtained from all the participants again in both experimental group and control group between 37 and 40 weeks of gestation in the form of hard copy questionnaire. Study procedures will be stopped for participants who delivered before the completion of the second administration of FOBS.
Participants in both experimental and control group will be contacted again at 1 month after childbirth. PMPS-E, PBQ, and EPDS will be administered. Participants will be provided with a link to access the online questionnaire.
Phase Two:
The first 30 participants who had undergone the art therapy sessions will be invited to participate in the individual semi-structured interviews. Interviews will be conducted face-to-face in a quiet and conducive room, or through phone call at 1 month after birth.
Interviews will be audio-recorded with permission from the participant and transcribed verbatim. The interview will be conducted by a trained midwife who is not involved in the art therapy sessions or the childbirth process of the participant.
Data Analysis:
Phase One: The following statistical analyses will be used. A value of p<0.05 will be assumed for the level of significance.
- Descriptive analysis will be used to describe the socio-demographic characteristics and all outcome variables (FOBS, PMPS-E, PBQ, and EPDS scores).
- Chi-squared test will be used to compare proportions of mode of birth and usage of epidural during labour between the experimental and control group.
- Paired sample t-test to compare the FOBS scores in the experimental group before and after intervention.
- Paired sample t-test to compare the FOBS scores in the control group in the second trimester and 37-40 weeks of pregnancy.
- Chi-squared test will be used to compare the number of pregnant women whose FOBS score decreased from ≥ 60 to a score less than 60 in both groups.
- Independent sample t-test will be used to compare all outcome variables (post FOBS, PMPS-E, PBQ, and EPDS scores) between the experimental and control groups.
- Pearson correlation analysis will be done to determine the associations between FOBS score and PMPS-E, PBQ, and EPDS scores of all participants.
- Pearson correlation analysis will be done to determine the associations between FOBS score and the socio-demographic variables.
- Univariate analysis will be done to compare the socio-demographic variables between the experimental and control groups.
- Regression analysis will be used to determine the predictors for FOC using the cut-off point for FOC (FOBS ≥ 60)
Phase Two:
Qualitative data will be analysed using thematic analysis, whereby data will be examined to identify common themes.
- Conditions
- Fear of Childbirth, Pregnancy Related, Anxiety and Fear, Anxiety, Fear
- Being tested
- Art Therapy
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art TherapyOther
Participants assigned to the Intervention (Art Therapy) arm will be offered a series of three to five art therapy sessions, depending on the participants' needs/preferences. The art therapy sessions will be given anytime after consent has been obtained till approximately 36 weeks of gestation. The Art Therapy is given in addition to routine antenatal care.
| Study group | Role | What they receive |
|---|---|---|
| Art Therapy | Experimental | Women in the experimental group will be offered a series of three to five art therapy sessions, depending on the participants' needs/preferences. The art therapy sessions will be given anytime after consent has been obtained till approximately 36 weeks of gestation. The art therapy sessions are in addition to routine antenatal care. Receives: Other: Art Therapy |
| Routine Antenatal Care | No intervention | Women in the control group will receive routine antenatal care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear or Childbirth (FOC)
FOC is measured by the Fear of Birth Scale (FOBS). The FOBS score ranges from 0 to 100. A higher score represents a higher value of fear of childbirth.
Measured: From Screening (Second Trimester) to between 37 and 40 Weeks of Gestation
Secondary outcomes (3)
Perceived Maternal Self-efficacy
The Perceived Maternal Parental Self-Efficacy (PMPS-E) scale is a self-reported questionnaire to assess maternal parenting self-efficacy among postpartum women. It consists of 20 items theorized from four subscales.
The PMPS-E scale ranges from 20 to 80. A higher score represents a higher level of maternal self-efficacy.
Measured: Measured after study intervention period, one month after childbirth
Maternal Infant Bonding
The Postpartum Bonding Questionnaire (PBQ) is a self-reported questionnaire consisting of 25 items to measure maternal infant bonding with four factors, namely general emotional factor, anger towards and rejection of baby, infant-focus anxiety, and risk of abuse. Total score ranges from 0 to 125, with higher values indicating more bonding difficulties.
Measured: Measured after study intervention period, one month after childbirth
Maternal Depression after Childbirth
The Edinburgh Postnatal Depression Scale (EPDS) is a self-reported questionnaire consisting of 10 items assessing symptoms of depression in the past week. There are four possible responses scored on a scale from 0 to 3. The total score is generated by summation of all items and ranges from 0 to 30.
Measured: Measured after study intervention period, one month after childbirth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start2 Nov 2023
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Fear of ChildbirthStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A mixed-methods sequential explanatory design will be used. Phase one will be quasi-experimental study design, comparing women with FOC who received art therapy (experimental group) and women who received routine antenatal care (control group). A qualitative descriptive design will be used in phase two to explore the experiences of the participants who had art therapy for FOC.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ang Mei Qi, KK Women's and Children's Hospital
- Investigators
- Mei Qi Ang, MSc(Nursing), Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257186
- Sponsor's protocol ID
- 2023/2493
- Status last verified
- Mar 2024
- First submitted
- 5 Feb 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adams SS, Eberhard-Gran M, Eskild A. Fear of childbirth and duration of labour: a study of 2206 women with intended vaginal delivery. BJOG. 2012 Sep;119(10):1238-46. doi: 10.1111/j.1471-0528.2012.03433.x. Epub 2012 Jun 27.
PubMed 22734617Alehagen S, Wijma B, Wijma K. Fear of childbirth before, during, and after childbirth. Acta Obstet Gynecol Scand. 2006;85(1):56-62. doi: 10.1080/00016340500334844.
PubMed 16521681Alipour Z, Lamyian M, Hajizadeh E. Anxiety and fear of childbirth as predictors of postnatal depression in nulliparous women. Women Birth. 2012 Sep;25(3):e37-43. doi: 10.1016/j.wombi.2011.09.002. Epub 2011 Sep 29.
PubMed 21959041Barnes CR, Adamson-Macedo EN. Perceived Maternal Parenting Self-Efficacy (PMP S-E) tool: development and validation with mothers of hospitalized preterm neonates. J Adv Nurs. 2007 Dec;60(5):550-60. doi: 10.1111/j.1365-2648.2007.04445.x.
PubMed 17973719Brockington IF, Fraser C, Wilson D. The Postpartum Bonding Questionnaire: a validation. Arch Womens Ment Health. 2006 Sep;9(5):233-42. doi: 10.1007/s00737-006-0132-1. Epub 2006 May 4.
PubMed 16673041Challacombe FL, Nath S, Trevillion K, Pawlby S, Howard LM. Fear of childbirth during pregnancy: associations with observed mother-infant interactions and perceived bonding. Arch Womens Ment Health. 2021 Jun;24(3):483-492. doi: 10.1007/s00737-020-01098-w. Epub 2020 Dec 17.
PubMed 33336315Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
PubMed 3651732Haines HM, Pallant JF, Fenwick J, Gamble J, Creedy DK, Toohill J, Hildingsson I. Identifying women who are afraid of giving birth: A comparison of the fear of birth scale with the WDEQ-A in a large Australian cohort. Sex Reprod Healthc. 2015 Dec;6(4):204-10. doi: 10.1016/j.srhc.2015.05.002. Epub 2015 May 15.
PubMed 26614602Hildingsson I, Rubertsson C. Depressive symptoms during pregnancy and after birth in women living in Sweden who received treatments for fear of birth. Arch Womens Ment Health. 2022 Apr;25(2):473-484. doi: 10.1007/s00737-022-01213-z. Epub 2022 Feb 21.
PubMed 35190877Hildingsson I, Rubertsson C. Postpartum bonding and association with depressive symptoms and prenatal attachment in women with fear of birth. BMC Pregnancy Childbirth. 2022 Jan 25;22(1):66. doi: 10.1186/s12884-021-04367-3.
PubMed 35078403Kinsella MT, Monk C. Impact of maternal stress, depression and anxiety on fetal neurobehavioral development. Clin Obstet Gynecol. 2009 Sep;52(3):425-40. doi: 10.1097/GRF.0b013e3181b52df1.
PubMed 19661759Nieminen K, Stephansson O, Ryding EL. Women's fear of childbirth and preference for cesarean section--a cross-sectional study at various stages of pregnancy in Sweden. Acta Obstet Gynecol Scand. 2009;88(7):807-13. doi: 10.1080/00016340902998436.
PubMed 19488882Nilsson C, Hessman E, Sjoblom H, Dencker A, Jangsten E, Mollberg M, Patel H, Sparud-Lundin C, Wigert H, Begley C. Definitions, measurements and prevalence of fear of childbirth: a systematic review. BMC Pregnancy Childbirth. 2018 Jan 12;18(1):28. doi: 10.1186/s12884-018-1659-7.
PubMed 29329526O'Connell MA, Leahy-Warren P, Khashan AS, Kenny LC, O'Neill SM. Worldwide prevalence of tocophobia in pregnant women: systematic review and meta-analysis. Acta Obstet Gynecol Scand. 2017 Aug;96(8):907-920. doi: 10.1111/aogs.13138. Epub 2017 May 17.
PubMed 28369672O'Connor TG, Heron J, Golding J, Beveridge M, Glover V. Maternal antenatal anxiety and children's behavioural/emotional problems at 4 years. Report from the Avon Longitudinal Study of Parents and Children. Br J Psychiatry. 2002 Jun;180:502-8. doi: 10.1192/bjp.180.6.502.
PubMed 12042228
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Art Therapy on Women With Fear of Childbirth During Pregnancy: A Mixed Method Study
- ClinicalTrials.gov ID
- NCT06257186
- Acronym / sponsor ID
- 2023/2493
- Conditions
- Fear of Childbirth, Pregnancy Related, Anxiety and Fear, Anxiety, Fear
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 13 Feb 2024 (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.
Childbirth is a multifaceted experience and could involve both positive and negative feelings. Feelings of limited capability in the face of childbirth may result in a condition termed as Fear of Childbirth (FOC), which contributes to significantly higher risks of birth complications resulting in psychological trauma. This study aims to examine the effects of Art Therapy (AT) on FOC, perceived maternal parental self-efficacy, postpartum maternal infant bonding and postpartum depression.
A mixed-methods sequential explanatory design will be used. Phase one will adopt a quasi-experimental study design. Women who are aged 21 and above, English literate and having a singleton pregnancy will be approached to fill in the Fear of Birth Scale (FOBS). Participants with FOBS score of 60 and above will be considered as having FOC and will be invited to participate in the AT intervention. Participants who are agreeable to receive AT will be recruited in the experimental group. Participants who declined to participate in AT will receive routine antenatal care (control group). Outcomes that will be measured in both groups include perceived maternal self-efficacy, maternal infant bonding, and maternal depression after childbirth. A qualitative descriptive design will be used in phase two. Semi-structured interviews will be conducted with the participants to explore their experiences of the AT. Descriptive analysis, independent sample t-test, paired sample t-test, and regression analysis will be used for analysis of the quantitative data in phase one. Qualitative data from phase two will be analysed using thematic analysis.
Findings of this study may provide evidence on the use of AT to cope with FOC during pregnancy. If proven to be beneficial, AT may potentially be introduced and advocated as an intervention for women with FOC.
Detailed description
Research Design:
A mixed-methods sequential explanatory design will be used. Phase one will be quasi-experimental study design, comparing women with FOC who received art therapy (experimental group) and women who received routine antenatal care (control group). A qualitative descriptive design will be used in phase two to explore the experiences of the participants who had art therapy for FOC.
Sampling:
Convenience sampling will be used for phase one. Purposive sampling will be used for phase two, for which only participants who had undergone the art therapy intervention will be invited to participate.
Consented participants will be invited to fill in the Fear of Birth Scale (FOBS). Participants with FOBS score of 60 and above will be enrolled into the study. Participants will be invited to participate in the Art Therapy intervention (experimental group). If participants are not agreeable to participate in the art therapy, they will be allocated to the control group.
Participants who had undergone the Art Therapy intervention will be invited to participate in phase two.
Sample Size:
Phase One: The study team is targeting to recruit 1200 participants to screen for FOC in phase one. Participants with FOC will be invited to continue participation in the quasi-experimental study with a target allocation of 1:1 in each group.
Phase Two: The sample size will be determined by data saturation, whereby no new information is identified from the data. This is estimated to be about sample size of 30 participants.
Data Collection Procedures:
Phase One:
Potential participants who are in the second trimester of their pregnancy (between 13 and 27 weeks of gestation) will be approached in the antenatal clinics. Details of the study will be explained using the Participant Information Sheet (PIS). After which, the FOBS will be used to measure the FOC. Recruited participants will be asked to fill in a hardcopy questionnaire.
After the participant has completed the questionnaire, the FOBS score will be tabulated and participants with FOBS score of more than or equal to 60 will be invited to participate in the intervention, which is a series of three to five art therapy sessions, depending on the participants' needs/preferences.
Women who are willing to participate in the art therapy sessions will be included in the experimental group, while women who received routine antenatal care but are not agreeable to participate in the art therapy sessions will be included in the control group. A study team member will contact the participants to arrange for the art therapy sessions and administration of the questionnaires.
A set of art materials will be provided to participants to use throughout the art therapy sessions, and to encourage participants to continue artmaking for self-care outside of sessions. The first session will be in a face-to-face format at a date and time agreed by the participant. Subsequent sessions will be offered via telehealth on dates and times agreed by the participant. Each session will last between 60 to 90 minutes and will be facilitated by an Art Therapist. Each session will be structured around themes aimed at building self-awareness, encouraging expressions of difficult emotions, strengthening the bond between participants and their child, and to facilitate the verbal counselling within the safety of art therapy session. FOBS score will be obtained from all the participants again in both experimental group and control group between 37 and 40 weeks of gestation in the form of hard copy questionnaire. Study procedures will be stopped for participants who delivered before the completion of the second administration of FOBS.
Participants in both experimental and control group will be contacted again at 1 month after childbirth. PMPS-E, PBQ, and EPDS will be administered. Participants will be provided with a link to access the online questionnaire.
Phase Two:
The first 30 participants who had undergone the art therapy sessions will be invited to participate in the individual semi-structured interviews. Interviews will be conducted face-to-face in a quiet and conducive room, or through phone call at 1 month after birth.
Interviews will be audio-recorded with permission from the participant and transcribed verbatim. The interview will be conducted by a trained midwife who is not involved in the art therapy sessions or the childbirth process of the participant.
Data Analysis:
Phase One: The following statistical analyses will be used. A value of p<0.05 will be assumed for the level of significance.
- Descriptive analysis will be used to describe the socio-demographic characteristics and all outcome variables (FOBS, PMPS-E, PBQ, and EPDS scores).
- Chi-squared test will be used to compare proportions of mode of birth and usage of epidural during labour between the experimental and control group.
- Paired sample t-test to compare the FOBS scores in the experimental group before and after intervention.
- Paired sample t-test to compare the FOBS scores in the control group in the second trimester and 37-40 weeks of pregnancy.
- Chi-squared test will be used to compare the number of pregnant women whose FOBS score decreased from ≥ 60 to a score less than 60 in both groups.
- Independent sample t-test will be used to compare all outcome variables (post FOBS, PMPS-E, PBQ, and EPDS scores) between the experimental and control groups.
- Pearson correlation analysis will be done to determine the associations between FOBS score and PMPS-E, PBQ, and EPDS scores of all participants.
- Pearson correlation analysis will be done to determine the associations between FOBS score and the socio-demographic variables.
- Univariate analysis will be done to compare the socio-demographic variables between the experimental and control groups.
- Regression analysis will be used to determine the predictors for FOC using the cut-off point for FOC (FOBS ≥ 60)
Phase Two:
Qualitative data will be analysed using thematic analysis, whereby data will be examined to identify common themes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A mixed-methods sequential explanatory design will be used. Phase one will be quasi-experimental study design, comparing women with FOC who received art therapy (experimental group) and women who received routine antenatal care (control group). A qualitative descriptive design will be used in phase two to explore the experiences of the participants who had art therapy for FOC.
| Arm | Type | Receives |
|---|---|---|
| Art Therapy | Experimental | Other: Art TherapyWomen in the experimental group will be offered a series of three to five art therapy sessions, depending on the participants' needs/preferences. The art therapy sessions will be given anytime after consent has been obtained till approximately 36 weeks of gestation. The art therapy sessions are in addition to routine antenatal care. |
| Routine Antenatal Care | No intervention | –Women in the control group will receive routine antenatal care. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged between 21 and 50 years old
- English literate
- Having an intrauterine singleton live pregnancy
- Currently in the second trimester of the pregnancy (between 13 to 27 weeks of pregnancy)
- Fear of Birth Scale (FOBS) score of 60 and above
Key exclusion criteria (5 listed)
- With contraindication for vaginal birth (for example placenta covering cervix)
- With obstetric complications during pregnancy such as fetal anomaly that is incompatible with life
- With current depression requiring medical intervention
- Who had stillborn delivery
- Phase II Inclusion Criteria Enrolled participants who had undergone the Art Therapy intervention in phase one
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 |
|---|---|---|
| Art TherapyParticipants assigned to the Intervention (Art Therapy) arm will be offered a series of three to five art therapy sessions, depending on the participants' needs/preferences. The art therapy sessions will be given anytime after consent has been obtained till approximately 36 weeks of gestation. The Art Therapy is given in addition to routine antenatal care. | Other | Art Therapy |
Primary outcome
Fear or Childbirth (FOC)
Time frame: From Screening (Second Trimester) to between 37 and 40 Weeks of Gestation
FOC is measured by the Fear of Birth Scale (FOBS). The FOBS score ranges from 0 to 100. A higher score represents a higher value of fear of childbirth.
3 secondary outcomes
Perceived Maternal Self-efficacy
Time frame: Measured after study intervention period, one month after childbirth
Maternal Infant Bonding
Time frame: Measured after study intervention period, one month after childbirth
Maternal Depression after Childbirth
Time frame: Measured after study intervention period, one month after childbirth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Background: PubMed 22734617Adams SS, Eberhard-Gran M, Eskild A. Fear of childbirth and duration of labour: a study of 2206 women with intended vaginal delivery. BJOG. 2012 Sep;119(10):1238-46. doi: 10.1111/j.1471-0528.2012.03433.x. Epub 2012 Jun 27.
- Background: PubMed 16521681Alehagen S, Wijma B, Wijma K. Fear of childbirth before, during, and after childbirth. Acta Obstet Gynecol Scand. 2006;85(1):56-62. doi: 10.1080/00016340500334844.
- Background: PubMed 21959041Alipour Z, Lamyian M, Hajizadeh E. Anxiety and fear of childbirth as predictors of postnatal depression in nulliparous women. Women Birth. 2012 Sep;25(3):e37-43. doi: 10.1016/j.wombi.2011.09.002. Epub 2011 Sep 29.
- Background: PubMed 17973719Barnes CR, Adamson-Macedo EN. Perceived Maternal Parenting Self-Efficacy (PMP S-E) tool: development and validation with mothers of hospitalized preterm neonates. J Adv Nurs. 2007 Dec;60(5):550-60. doi: 10.1111/j.1365-2648.2007.04445.x.
- Background: PubMed 16673041Brockington IF, Fraser C, Wilson D. The Postpartum Bonding Questionnaire: a validation. Arch Womens Ment Health. 2006 Sep;9(5):233-42. doi: 10.1007/s00737-006-0132-1. Epub 2006 May 4.
- Background: PubMed 33336315Challacombe FL, Nath S, Trevillion K, Pawlby S, Howard LM. Fear of childbirth during pregnancy: associations with observed mother-infant interactions and perceived bonding. Arch Womens Ment Health. 2021 Jun;24(3):483-492. doi: 10.1007/s00737-020-01098-w. Epub 2020 Dec 17.
- Background: PubMed 3651732Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
- Background: PubMed 26614602Haines HM, Pallant JF, Fenwick J, Gamble J, Creedy DK, Toohill J, Hildingsson I. Identifying women who are afraid of giving birth: A comparison of the fear of birth scale with the WDEQ-A in a large Australian cohort. Sex Reprod Healthc. 2015 Dec;6(4):204-10. doi: 10.1016/j.srhc.2015.05.002. Epub 2015 May 15.
- Background: PubMed 35190877Hildingsson I, Rubertsson C. Depressive symptoms during pregnancy and after birth in women living in Sweden who received treatments for fear of birth. Arch Womens Ment Health. 2022 Apr;25(2):473-484. doi: 10.1007/s00737-022-01213-z. Epub 2022 Feb 21.
- Background: PubMed 35078403Hildingsson I, Rubertsson C. Postpartum bonding and association with depressive symptoms and prenatal attachment in women with fear of birth. BMC Pregnancy Childbirth. 2022 Jan 25;22(1):66. doi: 10.1186/s12884-021-04367-3.
- Background: PubMed 19661759Kinsella MT, Monk C. Impact of maternal stress, depression and anxiety on fetal neurobehavioral development. Clin Obstet Gynecol. 2009 Sep;52(3):425-40. doi: 10.1097/GRF.0b013e3181b52df1.
- Background: PubMed 19488882Nieminen K, Stephansson O, Ryding EL. Women's fear of childbirth and preference for cesarean section--a cross-sectional study at various stages of pregnancy in Sweden. Acta Obstet Gynecol Scand. 2009;88(7):807-13. doi: 10.1080/00016340902998436.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sujitha L Kumar, BE(BioEng) contact
Mei Qi Ang, MSc(Nursing) principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art Therapy in people with Fear of Childbirth and Pregnancy Related, run by KK Women's and Children's Hospital at 1 site in Singapore.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Mar 2024. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mei Qi Ang, MSc(Nursing) (6530 3125, ang.mei.qi@kkh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear or Childbirth (FOC) (time frame: From Screening (Second Trimester) to between 37 and 40 Weeks of Gestation). 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 NCT06257186, which also lists 20 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 5 Mar 2024.