Coping Intervention After Embryo Transfer
Study of the Effectiveness of a Coping Selfhelp Intervention for Women in the Waiting Period After an Embryo Transfer During an IVF/ISCI Treatment
Background of the study:
Undergoing an IVF or ICSI treatment is an emotional and physical burden for both the woman and her partner. Most stressful for the couple is waiting for the result of the treatment, the period after the embryotransfer until the pregnancy test or menstruation and an unsuccessful treatment. Symptoms of anxiety and depression have been identified in couples during the waitingperiod after an embryotransfer. For this waitingperiod a short selfhelp copingintervention has been developed based on the stress theory of Lazarus for women to use at home. Goal of the instrument is to stimulate the copingstyle positive reappraisal. Research has demonstrated that using this copingstyle can have a positive impact in health related circumstances.
연구 개요
상세 설명
Objective of the study:
To investigate if a short copingintervention reduces anxiety in patients undergoing an IVF or ICSI treatment in the UMCU during the waitingperiod after an embryotransfer.
Study design:
In this research a randomised controlled trial (RCT) will be used for three groups. The choice for three groups has been based on earlier research with a daily record keeping (DRK). The DRK is a daily measurement for emotions, copingstyle and physical complaints. Previous research with the DRK showed an increase of anxiety. More research must be done of the impact of the DRK. Group 1: Positive Reappraisal Coping Intervention (PRCI) & DRK & questionnaires Group 2: DRK & questionnaires Group 3: Standard care & questionnaires
Study population:
Patients undergoing an IVF or ICSI treatment in the UMCU.
Intervention (if applicable):
A selfhelp coping intervention
Primary study parameters/outcome of the study:
Anxiety
Secondary study parameters/outcome of the study (if applicable):
Risk of emotional problems copingstyle depression vital pregnancy quality of life
Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):
Using the coping intervention may reduce anxiety for the patient. The use of this instrument is not a burden for patients. The burden for patients is to complete questionnaires before, during and six weeks after the embryotransfer. Partners are asked to fill in a questionnaire at three times.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Utrecht, 네덜란드, : PO Box 85500
- University Medical Center Utrecht
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patient in IVF/ICSI treatment
Exclusion Criteria:
- Patient who do not speak the dutch language
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: PRCI-monitoring
Coping intervention, Daily Record Keeping, Questionnaires
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Positive reappraisal coping intervention
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간섭 없음: Routine care control
Questionnaires
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간섭 없음: Monitoring control
DRK and Questionnaires
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Anxiety
기간: T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer
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The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983).
TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale.
The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21).
Scores on each scale can be interpreted in ranges: normal (0-7), mild (8-10), moderate (11-14) and severe (15-21) anxiety and depression.
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T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Depression
기간: T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer
|
The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983).
TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale.
The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21).
Scores on each scale can be interpreted in ranges: normal (0-7), mild (8-10), moderate (11-14) and severe (15-21) anxiety and depression.
|
T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: N.S. Macklon, MD, PhD, University of Southampton
- 수석 연구원: J Boivin, PhD, Cardiff University
간행물 및 유용한 링크
일반 간행물
- Ockhuijsen H, van den Hoogen A, Eijkemans M, Macklon N, Boivin J. The impact of a self-administered coping intervention on emotional well-being in women awaiting the outcome of IVF treatment: a randomized controlled trial. Hum Reprod. 2014 Jul;29(7):1459-70. doi: 10.1093/humrep/deu093. Epub 2014 May 7.
- Ockhuijsen HD, van den Hoogen A, Macklon NS, Boivin J. The PRCI study: design of a randomized clinical trial to evaluate a coping intervention for medical waiting periods used by women undergoing a fertility treatment. BMC Womens Health. 2013 Sep 3;13:35. doi: 10.1186/1472-6874-13-35.
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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