Effect of Social Support Program on Grief of Pregnancy Loss in Sunpasitthiprasong Hospital

NCT06295939 | Active Not Recruiting DMC

• 1 other identifier: CA code 016/2565, 012/2566
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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. 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. 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.
3. 3.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.
4. 4.To examine the grief and sorrow following pregnancy termination before returning home and one month after miscarriage.
5. 5.To explore other outcomes of pregnancy termination, such as complete abortion, uterine curettage, and post-miscarriage complications.

Conditions

Pregnancy Loss; Grief; Social Support

Keywords

Pregnancy Loss; Grief and Loss; Social support program

Outcome Measures

Primary Outcomes (1)

• The Perinatal Grief Assessment Questionnaire.

  The 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.

  1 month

Study Arms (2)

Group 1, the control group

EXPERIMENTAL

Group 1 the control group receive routine nursing care from the assigned nurse.

Other: Routine nursing care

Group 2: the experimental group

EXPERIMENTAL

Group 2, the experimental group, will receive regular nursing care from the assigned nurse and a social support program provided by the researcher Phase 1 (Before Pregnancy Termination) Phase 2 (After Pregnancy Termination, Before Returning Home)

Other: social support program; Other: Routine nursing care

Interventions

social support program OTHER

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) Phase 2 (After Pregnancy Termination, Before Returning Home):

Group 2: the experimental group

Routine nursing care OTHER

The sample group will receive routine nursing care from the assigned nurse.

Group 1, the control group; Group 2: the experimental group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women diagnosed with fetal demise and requiring pregnancy termination.
• Fetus with abnormalities requiring pregnancy termination.
• Age between 18 and 45 years.
• Gestational age not exceeding 24 weeks.
• No history of mental illness.
• No hearing, visual, speech impairments, and able to read and write in the Thai language.

You may not qualify if:

• Pregnant women diagnosed with an ectopic pregnancy.
• Presence of severe complications such as hemorrhage or shock.
• Women undergoing a pregnancy termination due to criminal abortion.

Sponsors & Collaborators

• Sanpasitthiprasong Hospital: lead

Study Sites (1)

Sanpasitthiprasong Hospital

Ubon Ratchathani, 34000, Thailand

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: March 6, 2024
• Study Start: April 29, 2022
• Primary Completion: March 15, 2024
• Study Completion: May 31, 2024
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)