Investigating the Effect of Art Therapy on Women With Fear of Childbirth During Pregnancy: A Mixed Method Study

March 1, 2024 updated by: Ang Mei Qi, KK Women's and Children's Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Phase I

Inclusion Criteria:

  1. Aged between 21 and 50 years old
  2. English literate
  3. Having an intrauterine singleton live pregnancy
  4. Currently in the second trimester of the pregnancy (between 13 to 27 weeks of pregnancy)
  5. Fear of Birth Scale (FOBS) score of 60 and above

Exclusion Criteria:

  1. With contraindication for vaginal birth (for example placenta covering cervix)
  2. With obstetric complications during pregnancy such as fetal anomaly that is incompatible with life
  3. With current depression requiring medical intervention
  4. Who had stillborn delivery

Phase II Inclusion Criteria Enrolled participants who had undergone the Art Therapy intervention in phase one

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Art Therapy
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.
Other: Art Therapy
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.
No Intervention: Routine Antenatal Care
Women in the control group will receive routine antenatal care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From Screening (Second Trimester) to between 37 and 40 Weeks of Gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal Infant Bonding
Time Frame: Measured after study intervention period, one month after childbirth
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 after study intervention period, one month after childbirth
Maternal Depression after Childbirth
Time Frame: Measured after study intervention period, one month 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 after study intervention period, one month after childbirth
Perceived Maternal Self-efficacy
Time Frame: Measured after study intervention period, one month after childbirth

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 after study intervention period, one month after childbirth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KK Women's and Children's Hospital

Investigators

  • Principal Investigator: Mei Qi Ang, MSc(Nursing), KK Women's and Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

February 5, 2024

First Submitted That Met QC Criteria

February 5, 2024

First Posted (Actual)

February 13, 2024

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/2493

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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