Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06257186
Status:
RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-02-05
Brief Title:
Investigating the Effect of Art Therapy on Women With Fear of Childbirth During Pregnancy A Mixed Method Study
Sponsor:
KK Womens and Childrens Hospital
Organization:
KK Womens and Childrens Hospital
Study Overview
Official Title:
Investigating the Effect of Art Therapy on Women With Fear of Childbirth During Pregnancy A Mixed Method Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 11 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 needspreferences
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 p005 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
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 11 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 needspreferences
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 p005 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None