Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06537570
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-01-15
Brief Title:
The Effect of Guided Imagery Practice on Psychosocial Health and Fear of Childbirth in Primiparous Pregnant Women
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Guided Imagery Practice on Psychosocial Health and Fear of Childbirth in Primiparous Pregnant Women A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Physical changes that occur during pregnancy transition to parenthood and taking on new responsibilities cause burden anxiety and stress in women and negatively affect psychosocial health One of the conditions that negatively affect psychosocial health during pregnancy is the fear of childbirth One of the current methods used in the management of the pregnancy process is guided imageryIt is known that guided imagery practice reduces stress and anxiety in pregnant women increases well-being and is beneficial to their daily lives contributes positively to mother-baby attachment and reduces pain in childbirth
Detailed Description:
21Study Design
This research was conducted as a randomized controlled experimental study to determine the effect of guided imagery on the psychosocial health and fear of childbirth of primiparous pregnant women The study was conducted between July 20 2022 and January 20 2023 with pregnant women admitted to the obstetrics and gynecology outpatient clinic of XXX Hospital in Gaziantep Turkey The hospital where the study was conducted has 7 gynecology outpatient clinics and 1 pregnancy school
22Sample
The population of the research consisted of all primiparous pregnant women in the 24-28th week of pregnancy The sample size was calculated using the G Power program Previous studies were examined and the expected confidence intervals of the Psychosocial Health Assessment Scale in Pregnancy PPHAS were determined and the confidence interval was calculated as 80 primiparous with α 005 test power 1-β 095 and effect size d 114 Minimum number of pregnant women required in the two groups was found to be 40 for the expectation that there would be a significant difference between the experimental group and the control group in terms of psychosocial health The sample of the study consisted of 80 pregnant women 40 in the experimental group and 40 in the control group The study reached 91 participants but 11 participants were excluded because they refused to participate in the study Figure 1 Medcalc version 18113 was used for the randomization list in assigning pregnant women to groups
Study inclusion criteria of volunteers
1 Volunteer to participate in the study
2 Having no condition to prevent communication
3 Age 18-35
4 No vision and hearing problems
5 At the 24th-28th week of pregnancy
6 With a single fetus
7 Primiparous pregnancies
Study exclusion criteria of volunteers
1 Illiterate
2 Before the 24th week of pregnancy
3 Having multiple pregnancies
4 Multiparous
5 With psychopathological disease
6 Pregnant women with medical or pregnancy complications
23Data Collection
Before the guided imagery application the language translation of the guided imagery usage steps guide prepared by Owen was done by a translation center in a certified manner Then a relaxing soothing soft and slow-paced CD consisting of mixed nature sounds photographs and music lasting 15 minutes and 50 seconds was prepared in the sound recording studio with the psychological counselor
Data collection forms were filled in by the researcher using face-to-face interview technique for the women who agreed to participate in the study The guided imagery video was shared with the women and they were made to watch it once a day for 12 weeks in a quiet calm uncrowded dimly lit room in their homes The women in the control group did not receive any interventions other than routine interventions during outpatient follow-up
24Data Collection Tools
In this study data collection tools were prepared by the researcher by reviewing the literature on the subject Data collection tools consist of three parts Annex-1
241Personal information form
The content of the personal information form consists of two parts The first part included questions about the socio-demographic characteristics of pregnant women age education level family type occupation and duration of marriage As for the second part there were questions about obstetric characteristics gestational week information about delivery miscarriage and abortion
242Psychosocial Health Assessment Scale in Pregnancy PPHAS
The Psychosocial Health Assessment Scale in Pregnancy was developed by Yıldız in 2011 as a scale consisting of six dimensions and 46 items to assess the psychosocial health of pregnant women In the scale the first sub-dimension evaluates Characteristics of pregnancy and spousal relationship the second sub-dimension evaluates Characteristics of anxiety and stress the third sub-dimension evaluates Characteristics of domestic violence the fourth sub-dimension evaluates Characteristics of psychosocial support need the fifth sub-dimension evaluates Family characteristics and the items in the sixth sub-dimension evaluates Characteristics of physical-psychosocial changes related to pregnancy In the scale it is stated that each item should be scored between 1-5 1 Not at all 2 A little 3 Moderately 4 A lot 5 Very much Before calculating the total score the score calculation of 29 items in the scale should be made by reversing the score calculation and the remaining 17 items should be evaluated as specified The minimum score that can be obtained from the scale is 46 and the maximum score is 230 The total score obtained from the scale is divided by the number of items to determine the mean value and a result between 1 and 5 is obtained As a result as the total score moves away from 5 and approaches 1 it indicates that there is a problem at that level in psychosocial health during pregnancy and a score of 1 indicates that psychosocial health is very poor In the validity and reliability study of the scale Cronbachs alpha reliability coefficient was found to be 09329 In this study Cronbachs alpha reliability coefficient was found to be 084
The score ranges in the evaluation of the PPHAS are as follows
179 Very low very bad
180 - 279 Low bad
280 - 339 Medium
340 - 419 Good
420 Very good
243Wijma Birth Expectation Experience Scale-A Version W-DEQ A Version
It was developed by Wijma et al 1988 to measure the fear of childbirth experienced by women The scale consists of 33 items The answers in the scale are numbered from 0 to 5 and are six-point Likert type 0 is expressed as completely and 5 is expressed as none While the minimum score on the scale is 0 the maximum score is 165 As the score increases the fear of childbirth experienced by women increases It is calculated by reversing 14 questions The clinical level of fear is 85 and above The scale which was adapted into Turkish by Körükcü et al 2008 and its validity and reliability was performed has a Cronbachs alpha value of 089 and Split-half reliability of 09130 In this study Cronbachs alpha reliability coefficient was found to be 079
Score ranges for the evaluation of Version A W-DEQ are as follows
W-DEQ score 37 indicates mild level fear
W-DEQ score 38-65 indicates moderate level fear
W-DEQ score 66-84 indicates severe level fear
W-DEQ score 85 indicates clinical level fear6
25Initiative
After interviewing the women who met the inclusion criteria the purpose of the study was explained and written informed consent was obtained from those who agreed to participate in the study The interventions are shown in the flow plan of the study Figure 2
251Procedures Applied to the Study Group
Pregnant women in the experimental group were administered pre-tests Personal Information Form Psychosocial Health Assessment Scale in Pregnancy and Wijma Birth Expectancy Experience Scale - A Version W-DEQ A Version just before watching the guided imagery video In the first interview with pregnant women video viewing days and hours were determined by giving information about the guided imagery video Pregnant women were then shown the guided imagery video consisting of a total of 12 weeks once a day for 15 minutes and 50 seconds Immediately after the 12-week period was completed post-tests Psychosocial Health Evaluation Scale in Pregnancy and Wijma Birth Expectancy Experience Scale - A Version W-DEQ A Version were administered to the pregnant women
252Procedures Applied to Control Group
Pregnant women in the control group were administered pre-tests Personal Information Form Psychosocial Health Assessment Scale in Pregnancy and Wijma Birth Expectancy Experience Scale - A Version W-DEQ A Version and post-tests Psychosocial Health Assessment Scale in Pregnancy and Wijma Birth Expectancy Experience Scale - A Version W-DEQ A Version 12 weeks later and no practice was performed except routine practices during outpatient follow-up
26Analysis
The data obtained from this study were coded by the researcher and then transferred to the SPSS for Windows 260 IBM Corp Armonk NY USA computer program and the necessary analyses were made in this program Shaphiro wilk test was applied to determine whether the scores of the pregnant women from the scales showed normal distribution In the comparison of numerical variables in 2 independent groups data with normal distribution were analyzed by Student t test One-factor ANOVA for dependent samples was used to determine the effect of guided imagery on PPHAS and W-DEQ A Effect sizes were calculated with partial Eta squared ηp2 and if they were calculated between 00 and 30 they were considered very low if they were between 30 and 50 they were considered low If they were between 50 and 70 they were considered moderate if they were between 70 and 90 they were considered high if they were between 90 and 100 they were considered very high31 Paired Sample t-test was used for the pre-test and post-test comparison of the subscales of PPHAS and W-DEQ A in the dependent group The significance level was taken as p 005
This research was conducted as a randomized controlled experimental study to determine the effect of guided imagery on the psychosocial health and fear of childbirth of primiparous pregnant women The study was conducted between July 20 2022 and January 20 2023 with pregnant women admitted to the obstetrics and gynecology outpatient clinic of XXX Hospital in Gaziantep Turkey The hospital where the study was conducted has 7 gynecology outpatient clinics and 1 pregnancy school
22Sample
The population of the research consisted of all primiparous pregnant women in the 24-28th week of pregnancy The sample size was calculated using the G Power program Previous studies were examined and the expected confidence intervals of the Psychosocial Health Assessment Scale in Pregnancy PPHAS were determined and the confidence interval was calculated as 80 primiparous with α 005 test power 1-β 095 and effect size d 114 Minimum number of pregnant women required in the two groups was found to be 40 for the expectation that there would be a significant difference between the experimental group and the control group in terms of psychosocial health The sample of the study consisted of 80 pregnant women 40 in the experimental group and 40 in the control group The study reached 91 participants but 11 participants were excluded because they refused to participate in the study Figure 1 Medcalc version 18113 was used for the randomization list in assigning pregnant women to groups
Study inclusion criteria of volunteers
1 Volunteer to participate in the study
2 Having no condition to prevent communication
3 Age 18-35
4 No vision and hearing problems
5 At the 24th-28th week of pregnancy
6 With a single fetus
7 Primiparous pregnancies
Study exclusion criteria of volunteers
1 Illiterate
2 Before the 24th week of pregnancy
3 Having multiple pregnancies
4 Multiparous
5 With psychopathological disease
6 Pregnant women with medical or pregnancy complications
23Data Collection
Before the guided imagery application the language translation of the guided imagery usage steps guide prepared by Owen was done by a translation center in a certified manner Then a relaxing soothing soft and slow-paced CD consisting of mixed nature sounds photographs and music lasting 15 minutes and 50 seconds was prepared in the sound recording studio with the psychological counselor
Data collection forms were filled in by the researcher using face-to-face interview technique for the women who agreed to participate in the study The guided imagery video was shared with the women and they were made to watch it once a day for 12 weeks in a quiet calm uncrowded dimly lit room in their homes The women in the control group did not receive any interventions other than routine interventions during outpatient follow-up
24Data Collection Tools
In this study data collection tools were prepared by the researcher by reviewing the literature on the subject Data collection tools consist of three parts Annex-1
241Personal information form
The content of the personal information form consists of two parts The first part included questions about the socio-demographic characteristics of pregnant women age education level family type occupation and duration of marriage As for the second part there were questions about obstetric characteristics gestational week information about delivery miscarriage and abortion
242Psychosocial Health Assessment Scale in Pregnancy PPHAS
The Psychosocial Health Assessment Scale in Pregnancy was developed by Yıldız in 2011 as a scale consisting of six dimensions and 46 items to assess the psychosocial health of pregnant women In the scale the first sub-dimension evaluates Characteristics of pregnancy and spousal relationship the second sub-dimension evaluates Characteristics of anxiety and stress the third sub-dimension evaluates Characteristics of domestic violence the fourth sub-dimension evaluates Characteristics of psychosocial support need the fifth sub-dimension evaluates Family characteristics and the items in the sixth sub-dimension evaluates Characteristics of physical-psychosocial changes related to pregnancy In the scale it is stated that each item should be scored between 1-5 1 Not at all 2 A little 3 Moderately 4 A lot 5 Very much Before calculating the total score the score calculation of 29 items in the scale should be made by reversing the score calculation and the remaining 17 items should be evaluated as specified The minimum score that can be obtained from the scale is 46 and the maximum score is 230 The total score obtained from the scale is divided by the number of items to determine the mean value and a result between 1 and 5 is obtained As a result as the total score moves away from 5 and approaches 1 it indicates that there is a problem at that level in psychosocial health during pregnancy and a score of 1 indicates that psychosocial health is very poor In the validity and reliability study of the scale Cronbachs alpha reliability coefficient was found to be 09329 In this study Cronbachs alpha reliability coefficient was found to be 084
The score ranges in the evaluation of the PPHAS are as follows
179 Very low very bad
180 - 279 Low bad
280 - 339 Medium
340 - 419 Good
420 Very good
243Wijma Birth Expectation Experience Scale-A Version W-DEQ A Version
It was developed by Wijma et al 1988 to measure the fear of childbirth experienced by women The scale consists of 33 items The answers in the scale are numbered from 0 to 5 and are six-point Likert type 0 is expressed as completely and 5 is expressed as none While the minimum score on the scale is 0 the maximum score is 165 As the score increases the fear of childbirth experienced by women increases It is calculated by reversing 14 questions The clinical level of fear is 85 and above The scale which was adapted into Turkish by Körükcü et al 2008 and its validity and reliability was performed has a Cronbachs alpha value of 089 and Split-half reliability of 09130 In this study Cronbachs alpha reliability coefficient was found to be 079
Score ranges for the evaluation of Version A W-DEQ are as follows
W-DEQ score 37 indicates mild level fear
W-DEQ score 38-65 indicates moderate level fear
W-DEQ score 66-84 indicates severe level fear
W-DEQ score 85 indicates clinical level fear6
25Initiative
After interviewing the women who met the inclusion criteria the purpose of the study was explained and written informed consent was obtained from those who agreed to participate in the study The interventions are shown in the flow plan of the study Figure 2
251Procedures Applied to the Study Group
Pregnant women in the experimental group were administered pre-tests Personal Information Form Psychosocial Health Assessment Scale in Pregnancy and Wijma Birth Expectancy Experience Scale - A Version W-DEQ A Version just before watching the guided imagery video In the first interview with pregnant women video viewing days and hours were determined by giving information about the guided imagery video Pregnant women were then shown the guided imagery video consisting of a total of 12 weeks once a day for 15 minutes and 50 seconds Immediately after the 12-week period was completed post-tests Psychosocial Health Evaluation Scale in Pregnancy and Wijma Birth Expectancy Experience Scale - A Version W-DEQ A Version were administered to the pregnant women
252Procedures Applied to Control Group
Pregnant women in the control group were administered pre-tests Personal Information Form Psychosocial Health Assessment Scale in Pregnancy and Wijma Birth Expectancy Experience Scale - A Version W-DEQ A Version and post-tests Psychosocial Health Assessment Scale in Pregnancy and Wijma Birth Expectancy Experience Scale - A Version W-DEQ A Version 12 weeks later and no practice was performed except routine practices during outpatient follow-up
26Analysis
The data obtained from this study were coded by the researcher and then transferred to the SPSS for Windows 260 IBM Corp Armonk NY USA computer program and the necessary analyses were made in this program Shaphiro wilk test was applied to determine whether the scores of the pregnant women from the scales showed normal distribution In the comparison of numerical variables in 2 independent groups data with normal distribution were analyzed by Student t test One-factor ANOVA for dependent samples was used to determine the effect of guided imagery on PPHAS and W-DEQ A Effect sizes were calculated with partial Eta squared ηp2 and if they were calculated between 00 and 30 they were considered very low if they were between 30 and 50 they were considered low If they were between 50 and 70 they were considered moderate if they were between 70 and 90 they were considered high if they were between 90 and 100 they were considered very high31 Paired Sample t-test was used for the pre-test and post-test comparison of the subscales of PPHAS and W-DEQ A in the dependent group The significance level was taken as p 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None