An interventional study of Meditation and mindfulness in Recurrent Pregnancy Loss, sponsored by Henriette Svarre Nielsen, MD, DMSc. Status unknown at 1 site in Denmark. Open to female participants aged 18 Years to 46 Years. Per ClinicalTrials.gov, last updated 2019-04-05.
Sponsored by Henriette Svarre Nielsen, MD, DMSc · Not applicable, Interventional, and Treatment
In the Danish Recurrent Pregnancy Loss Unit in Rigshospitalet in Copenhagen recurrent pregnancy loss (RPL) is defined as three og more consecutive pregnancy losses in accordance with current European guidelines.
RPL affects approximately 3% of couples trying to achieve parenthood. Most cases of RPL are unexplained and have no effective treatment to improve the chance of a live birth.
42% of the women referred to RPL Unit in Rigshospitalet has a high stress level where as it's 22% in the background population trying to achieve parenthood. It's also known that 8,8 % of RPL patients have a depression at referral where as it's 2,2 % in the background population trying to achieve parenthood.
The study is a RCT including 62 patients - 31 in each arm. One arm will be taught in meditation and mindfulness three courses over a 7 week period. This group will also do meditation every day for 7 weeks. The other arm will have no intervention.
This study will investigate if a 7 weeks course in meditation and mindfulness is a useful tool to reduce stress and the psychological consequences for women and their partner treated in RPL Unit in Rigshospitalet, Copenhagen. Furthermore this study will investigate if there's a marital benefit such as reinforcement in their relationsship from practicing meditation and mindfulness.
There is no previous study that has investigated meditation and mindfulness for RPL.
This study has the potential to establish mental health support as a supplement to the medical and clinical treatment for RPL patients.
The loss of a desired pregnancy is a significant negative life event associated with grief comparable to the grief after a peri- or neonatal death. Recurrent pregnancy loss (RPL) defined as 3 or more pregnancy losses affects approximately 3% of couples trying to have children. Most cases of RPL are unexplained and have no effective treatment to improve the chance of a live birth.
42% of the women referred to RPL Unit in Rigshospitalet has a high stress level where as it's 22% in the background population trying to achieve parenthood. It's also known that 8,8% of RPL patients have a depression at referral where as it's 2,2 % in the background population trying to achieve parenthood.
This study will investigate if a 7 weeks course in meditation and mindfulness is a useful tool to reduce stress and the psychological consequences for women and their partner treated in RPL Unit in Rigshospitalet, Copenhagen.
Furthermore this study will investigate if there's a marital benefit from practicing meditation and mindfulness. The investigators will use four different scales to measure the participants stress, depression, marital benefit and fertility stress. Also the investigators will measure the participants before and after the intervention and 12 months after.
All participants will have to complete:
The investigators assume that meditation and mindfulness can improve the quality of life for the RPL patients and their coping strategies. It's the investigators purpose to contribute with new knowledge in this area for current and future patients.
The RPL Unit in Rigshospitalet doesn't have any psychological support apart from ordinary attention from the nurses. This study has the potential to establish mental health support as a supplement to the medical and clinical treatment for RPL patients, which is in high demand.
320 studies on the registry are indexed under Abortion, Spontaneous; 53 are open to participants now.
This study's planned enrollment of 64 is below the median of 147 across 174 interventional studies indexed under Abortion, Spontaneous.
Browse Abortion, Spontaneous studies →This is the only study on the registry with Henriette Svarre Nielsen, MD, DMSc as lead sponsor.
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Exclusion Criteria:
Women in the intervention arm will 3 times receive a three hours work shop with introduction to meditation and mindfulness over a 7 week period from a certified meditation instructor. Questionnaires before and after the intervention.
Behavioral: Meditation and mindfulness
Women in the no intervention arm will receive no introduction to meditation and mindfulness - only questionnaires at the same time as the intervention group receives questionnaires.
Women in the intervention arm will 3 times receive a three hours work shop with introduction to meditation and mindfulness over a 7 week period from a certified meditation instructor. Questionnaires before and after the intervention.
Perceived Stress Scale (PSS)
Change from baseline to 7 weeks after date of first course day measured by Perceived Stress Scale. PSS is a validated 10-item-self-reporting scale for stress symptoms. The 5 point Likert scale ranges from 0 (no stress) to 40 (extreme stress). The higher score the more stress.
Time frame: 7 weeks
Perceived Stress Scale (PSS)
Change from baseline to 12 months after date of first course day measured by the Perceived Stress Scale. PSS is a validated 10-item-self-reporting scale for stress symptoms. The 5 point Likert scale ranges from 0 (no stress) to 40 (extreme stress). The higher score the more stress.
Time frame: 12 months
COMPI Fertility Problem Stress Scale
Change from baseline to 7 weeks after date of first course day using the COMPI Fertility Problem Stress Scale. The COMPI Fertility Problem Stress Scale is a validated scale measuring the impact of RPL on the woman and her interpersonal relationships. Two questions asking if the experience of RPL has been stressful for the woman with five answering options. Followed by seven sub questions asking how big a load RPL has been for the patients interpersonal life with four answering options. The lower the score the higher stress.
Time frame: 7 weeks
Marital Benefit Scale
Change in marital benefit from baseline to 7 weeks after date of first course day using the COMPI Marital Benefit Scale. The COMPI Marital Benefit Scale has two questions asking what the RPL have mattered for their relationship/mariage: Five options to answer: totally disagree, partly disagree, neither agree or disagree, partly agree, totally agree. Answering "Totally agree" on both questions is defined as a high marital benefit.
Time frame: 7 weeks
COMPI Fertility Problem Stress Scale
Change in fertility problem stress from baseline to 12 months after date of first course day using the COMPI Fertility Problem Stress Scale. The COMPI Fertility Problem Stress Scale is a validated scale measuring the impact of RPL on the woman and her interpersonal relationships. Two questions used to assess how big a impact RPL has for the patient with five answering options. Followed by seven sub questions asking how big a load RPL has been for the patients interpersonal life with four answering options. The lower the score the higher stress.
Time frame: 12 months
Marital Benefit
Change in marital benefit from baseline to 12 months after date of first course day using the COMPI Marital Benefit Scale. The COMPI Marital Benefit Scale has two questions asking what the RPL have mattered for their relationship/mariage: Five options to answer: totally disagree, partly disagree, neither agree or disagree, partly agree, totally agree. Answering "Totally agree" on both questions is defined as a high marital benefit.
Time frame: 12 months
Major Depression Index (MDI)
Change in depression score from baseline to 12 months after date of first course day. Major Depression Index is a validated self-rating depression scale, which is used both clinically and in epidemiological studie. The 6-point Likert scale ranges from 0 (no depression) to 50 (extreme depression).
Time frame: 12 months
Plan to share: No
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