Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06295939
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-02-14
Brief Title:
Effect of Social Support Program on Grief of Pregnancy Loss in Sunpasitthiprasong Hospital
Sponsor:
Sanpasitthiprasong Hospital
Organization:
Sanpasitthiprasong Hospital
Study Overview
Official Title:
Effect of Social Support Program on Grief of Pregnancy Loss in Sunpasitthiprasong Hospital a Randomized Controlled Trial
Status:
ACTIVE_NOT_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:
Research Question
Does participation in a social support program have an impact on the Perinatal Grief Scale of women who experience pregnancy loss through abortion Research hypothesis
1 The grief scores from pregnancy loss among women who had to terminate their pregnancies in the group receiving social support program were lower than those in the group receiving standard nursing care
2 The grief scores from pregnancy loss among women who had to terminate their pregnancies after receiving the social support program were lower than those before receiving the social support program
Primary Objectives
To study the grief and sorrow resulting from the loss of a fetus due to pregnancy termination in women who have undergone social support programs in comparison to those who have received regular nursing care
Secondary Objectives
1 To investigate the grief and sorrow resulting from the loss of a fetus due to pregnancy termination after receiving social support programs compared to before receiving such programs
2 To examine the grief and sorrow following pregnancy termination before returning home and one month after miscarriage
3 To explore other outcomes of pregnancy termination such as complete abortion uterine curettage and post-miscarriage complications
Does participation in a social support program have an impact on the Perinatal Grief Scale of women who experience pregnancy loss through abortion Research hypothesis
1 The grief scores from pregnancy loss among women who had to terminate their pregnancies in the group receiving social support program were lower than those in the group receiving standard nursing care
2 The grief scores from pregnancy loss among women who had to terminate their pregnancies after receiving the social support program were lower than those before receiving the social support program
Primary Objectives
To study the grief and sorrow resulting from the loss of a fetus due to pregnancy termination in women who have undergone social support programs in comparison to those who have received regular nursing care
Secondary Objectives
1 To investigate the grief and sorrow resulting from the loss of a fetus due to pregnancy termination after receiving social support programs compared to before receiving such programs
2 To examine the grief and sorrow following pregnancy termination before returning home and one month after miscarriage
3 To explore other outcomes of pregnancy termination such as complete abortion uterine curettage and post-miscarriage complications
Detailed Description:
Research Methodology
The research is a randomized controlled trial RCT of the single-blinded type In this design the evaluator or research assistant is unaware of the participants group assignments meaning they do not know which individuals belong to the experimental group and which ones belong to the control group
Population and Sample
Population The population for this study comprises females who have undergone abortion and are admitted for post-abortion care at the obstetrics 3 wards in Sunpasitthiprasong hospital
Sample The sample for this study will be selected from the aforementioned population The selection criteria for the sample are defined as follows
1 Pregnant women diagnosed with fetal demise and requiring pregnancy termination
2 Fetus with abnormalities requiring pregnancy termination
3 Age between 18 and 45 years
4 Gestational age not exceeding 24 weeks
5 No history of mental illness
6 No hearing visual speech impairments and able to read and write in the Thai language
Exclusion Criteria
1 Pregnant women diagnosed with an ectopic pregnancy
2 Presence of severe complications such as hemorrhage or shock
3 Women undergoing a pregnancy termination due to criminal abortion
Research Tools
Experimental Tools
Social Support Program
11 The social support program is developed based on the conceptual framework by House 1981 and is informed by relevant literature textbooks and research studies The program is designed to provide support in two phases Phase 1 Before the abortion procedure Phase 2 After the abortion procedure 12 Abortion Education Plan The educational plan includes instructional content on abortion methods of abortion pain relief during abortion post-abortion self-care grief and loss and coping with sadness
13 Self-Care Manual for Women Undergoing Abortion This manual encompasses guidance on abortion abortion methods pain relief during abortion post-abortion self-care dealing with grief and grief management
Data Collection Tools
21 Personal Information and Pregnancy Data Questionnaire A questionnaire capturing personal information and pregnancy-related data Includes items such as age marital status occupation education level family income healthcare entitlement desire for children before diagnosis of fetal abnormality gestational age at the time of abortion abnormality leading to abortion abortion method duration of the abortion procedure completeness of the abortion and complications arising from the abortion
22 Perinatal Grief Assessment Questionnaire Perinatal Grief Scale short version - PGS-33 This questionnaire translated into Thai by Sukanya Kritiyutanon 2014 and adjusted based on expert suggestions comprises 33 questions It evaluates grief on three dimensions Active grief Difficulty coping and Despair Each question is rated on a 5-point Likert scale Strongly Agree to Strongly Disagree with scores ranging from 33 to 165 The higher the score the higher the level of grief Scores above 91 indicate a high level of grief
Data Collection
1 The researcher provided information about a research project involving pregnant women diagnosed with fetal demise or abnormalities who are recommended to undergo pregnancy termination at the third trimester abortion clinic
2 Pregnant women voluntarily consent to participate in the research by signing the informed consent form
3 Volunteer participants providing consent will be randomly divided into two groups using the randomization technique with Excel program
4 Divide into groups of 45 individuals each totaling 90 participants in the entire sample
Group 1 the control group Researchers will meet with the sample group on the first day of their stay at the patient care center Participants will respond to personal information and a questionnaire assessing grief from pregnancy loss Subsequently the sample group will receive routine nursing care from the assigned nurse who will explain the treatment plan provided by the physician follow the physicians treatment orders and provide post-abortion care On the morning of that day the research assistant a nurse from obstetrics 3 ward on duty will visit the sample group to administer the grief assessment questionnaire
Group 2 the experimental group will receive routine nursing care from the assigned nurse and a social support program provided by the researcher as follows
Phase 1 Before Pregnancy Termination On the first day of their stay at the hospital the researcher will meet with the sample group Participants will respond to a general information questionnaire and an assessment of grief from pregnancy loss Subsequently the sample group will receive nursing care according to the social support program The researcher will establish rapport provide information about the reasons for pregnancy termination explain the steps of the procedure discuss potential symptoms after termination teach pain management techniques during the procedure and engage in supportive conversations This session will last approximately 30 minutes
Phase 2 After Pregnancy Termination Before Returning Home Before leaving the hospital the researcher will provide information about potential post-abortion symptoms such as mild abdominal pain that may gradually subside a gradual decrease in vaginal bleeding within 1-2 weeks and instructions to seek medical attention if bleeding persists there is a foul smell or if the patient develops a fever The researcher will also offer knowledge about grief provide emotional support and discuss self-care after pregnancy termination Additionally information will be given about preparing for future pregnancies This session will take about 30 minutes A follow-up appointment will be scheduled for a post-abortion checkup with the nurse from obstetrics 3 ward on duty on the same morning who will administer the grief assessment questionnaire
5 The researcher scheduled appointments for both the control and experimental groups on the same day as the post-abortion checkup with the physician 1 month after pregnancy termination The research assistant administered the grief assessment questionnaire to both the control and experimental groups during this follow-up appointment
6 The researcher recorded pregnancy childbirth and outcomes of pregnancy termination data including the desire for pregnancy before diagnosis of fetal abnormalities gestational age at the time of pregnancy termination fetal abnormalities leading to termination termination methods duration of the termination procedure completeness of abortion the use of dilation and curettage and complications resulting from pregnancy termination
The duration of hospital stay could not be specified and depended on the physicians treatment plan but typically did not exceed 24-48 hours after completing the abortion
Data collection and management include a Questionnaire and The researcher analyzed the data using the SPSS version 250 statistical
1 Descriptive Data Analysis Descriptive statistics including counts percentages mean standard deviation SD median and interquartile range
2 Comparison of Depression Scores between Control and Experimental Groups after Receiving the Program Independent t-test and Mann-Whitney U test were utilized for normally distributed and non-normally distributed data respectively
3 Comparison of Depression Scores before and after Program Implementation Paired t-test was employed to compare depression scores before and after the program
4 Comparison of Categorical Data Chi-square test and Fishers exact test were used for analyzing count data
5 Intention-to-Treat Analysis The intention-to-treat principle was applied considering a statistical significance level of 05
The research is a randomized controlled trial RCT of the single-blinded type In this design the evaluator or research assistant is unaware of the participants group assignments meaning they do not know which individuals belong to the experimental group and which ones belong to the control group
Population and Sample
Population The population for this study comprises females who have undergone abortion and are admitted for post-abortion care at the obstetrics 3 wards in Sunpasitthiprasong hospital
Sample The sample for this study will be selected from the aforementioned population The selection criteria for the sample are defined as follows
1 Pregnant women diagnosed with fetal demise and requiring pregnancy termination
2 Fetus with abnormalities requiring pregnancy termination
3 Age between 18 and 45 years
4 Gestational age not exceeding 24 weeks
5 No history of mental illness
6 No hearing visual speech impairments and able to read and write in the Thai language
Exclusion Criteria
1 Pregnant women diagnosed with an ectopic pregnancy
2 Presence of severe complications such as hemorrhage or shock
3 Women undergoing a pregnancy termination due to criminal abortion
Research Tools
Experimental Tools
Social Support Program
11 The social support program is developed based on the conceptual framework by House 1981 and is informed by relevant literature textbooks and research studies The program is designed to provide support in two phases Phase 1 Before the abortion procedure Phase 2 After the abortion procedure 12 Abortion Education Plan The educational plan includes instructional content on abortion methods of abortion pain relief during abortion post-abortion self-care grief and loss and coping with sadness
13 Self-Care Manual for Women Undergoing Abortion This manual encompasses guidance on abortion abortion methods pain relief during abortion post-abortion self-care dealing with grief and grief management
Data Collection Tools
21 Personal Information and Pregnancy Data Questionnaire A questionnaire capturing personal information and pregnancy-related data Includes items such as age marital status occupation education level family income healthcare entitlement desire for children before diagnosis of fetal abnormality gestational age at the time of abortion abnormality leading to abortion abortion method duration of the abortion procedure completeness of the abortion and complications arising from the abortion
22 Perinatal Grief Assessment Questionnaire Perinatal Grief Scale short version - PGS-33 This questionnaire translated into Thai by Sukanya Kritiyutanon 2014 and adjusted based on expert suggestions comprises 33 questions It evaluates grief on three dimensions Active grief Difficulty coping and Despair Each question is rated on a 5-point Likert scale Strongly Agree to Strongly Disagree with scores ranging from 33 to 165 The higher the score the higher the level of grief Scores above 91 indicate a high level of grief
Data Collection
1 The researcher provided information about a research project involving pregnant women diagnosed with fetal demise or abnormalities who are recommended to undergo pregnancy termination at the third trimester abortion clinic
2 Pregnant women voluntarily consent to participate in the research by signing the informed consent form
3 Volunteer participants providing consent will be randomly divided into two groups using the randomization technique with Excel program
4 Divide into groups of 45 individuals each totaling 90 participants in the entire sample
Group 1 the control group Researchers will meet with the sample group on the first day of their stay at the patient care center Participants will respond to personal information and a questionnaire assessing grief from pregnancy loss Subsequently the sample group will receive routine nursing care from the assigned nurse who will explain the treatment plan provided by the physician follow the physicians treatment orders and provide post-abortion care On the morning of that day the research assistant a nurse from obstetrics 3 ward on duty will visit the sample group to administer the grief assessment questionnaire
Group 2 the experimental group will receive routine nursing care from the assigned nurse and a social support program provided by the researcher as follows
Phase 1 Before Pregnancy Termination On the first day of their stay at the hospital the researcher will meet with the sample group Participants will respond to a general information questionnaire and an assessment of grief from pregnancy loss Subsequently the sample group will receive nursing care according to the social support program The researcher will establish rapport provide information about the reasons for pregnancy termination explain the steps of the procedure discuss potential symptoms after termination teach pain management techniques during the procedure and engage in supportive conversations This session will last approximately 30 minutes
Phase 2 After Pregnancy Termination Before Returning Home Before leaving the hospital the researcher will provide information about potential post-abortion symptoms such as mild abdominal pain that may gradually subside a gradual decrease in vaginal bleeding within 1-2 weeks and instructions to seek medical attention if bleeding persists there is a foul smell or if the patient develops a fever The researcher will also offer knowledge about grief provide emotional support and discuss self-care after pregnancy termination Additionally information will be given about preparing for future pregnancies This session will take about 30 minutes A follow-up appointment will be scheduled for a post-abortion checkup with the nurse from obstetrics 3 ward on duty on the same morning who will administer the grief assessment questionnaire
5 The researcher scheduled appointments for both the control and experimental groups on the same day as the post-abortion checkup with the physician 1 month after pregnancy termination The research assistant administered the grief assessment questionnaire to both the control and experimental groups during this follow-up appointment
6 The researcher recorded pregnancy childbirth and outcomes of pregnancy termination data including the desire for pregnancy before diagnosis of fetal abnormalities gestational age at the time of pregnancy termination fetal abnormalities leading to termination termination methods duration of the termination procedure completeness of abortion the use of dilation and curettage and complications resulting from pregnancy termination
The duration of hospital stay could not be specified and depended on the physicians treatment plan but typically did not exceed 24-48 hours after completing the abortion
Data collection and management include a Questionnaire and The researcher analyzed the data using the SPSS version 250 statistical
1 Descriptive Data Analysis Descriptive statistics including counts percentages mean standard deviation SD median and interquartile range
2 Comparison of Depression Scores between Control and Experimental Groups after Receiving the Program Independent t-test and Mann-Whitney U test were utilized for normally distributed and non-normally distributed data respectively
3 Comparison of Depression Scores before and after Program Implementation Paired t-test was employed to compare depression scores before and after the program
4 Comparison of Categorical Data Chi-square test and Fishers exact test were used for analyzing count data
5 Intention-to-Treat Analysis The intention-to-treat principle was applied considering a statistical significance level of 05
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