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

NCT06257186 | Recruiting

• 1 other identifier: 2023/2493
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Fear of Childbirth; Pregnancy Related; Anxiety and Fear; Anxiety; Fear

Outcome Measures

Primary Outcomes (1)

• 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.

  From Screening (Second Trimester) to between 37 and 40 Weeks of Gestation

Secondary Outcomes (3)

• Perceived Maternal Self-efficacy

  Measured after study intervention period, one month after childbirth

• Maternal Infant Bonding

  Measured after study intervention period, one month after childbirth

• Maternal Depression after Childbirth

  Measured after study intervention period, one month after childbirth

Study Arms (2)

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.

Other: Art Therapy

Routine Antenatal Care

NO INTERVENTION

Women in the control group will receive routine antenatal care.

Interventions

Art Therapy OTHER

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.

Art Therapy

Eligibility Criteria

• Age: 21 Years - 50 Years
• Gender Eligibility Details: Only females will be included in this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, Singapore

RECRUITING

Related Publications (19)

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  PMID: 16673041 BACKGROUND

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  PMID: 33336315 BACKGROUND

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  PMID: 3651732 BACKGROUND

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  PMID: 26614602 BACKGROUND

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  PMID: 35190877 BACKGROUND

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  PMID: 35078403 BACKGROUND

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  PMID: 19661759 BACKGROUND

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  PMID: 19488882 BACKGROUND

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• Slade P, Balling K, Sheen K, Houghton G. Establishing a valid construct of fear of childbirth: findings from in-depth interviews with women and midwives. BMC Pregnancy Childbirth. 2019 Mar 18;19(1):96. doi: 10.1186/s12884-019-2241-7.

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MeSH Terms

Conditions

Anxiety Disorders

Interventions

Art Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Mei Qi Ang, MSc(Nursing)

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei Qi Ang, MSc(Nursing)

CONTACT

6530 3125; ang.mei.qi@kkh.com.sg

Sujitha L Kumar, BE(BioEng)

CONTACT

sujitha.lakshmana.kumar@kkh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Clinician

Model Details: 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.

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: November 2, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)