Clinical trial NCT03905395: Meditation and Mindfulness for Recurrent Pregnancy Loss
Official title: Meditation and Mindfulness for Recurrent Pregnancy Loss
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Recurrent Pregnancy Loss
Keywords: Meditation
mindfulness
pregnancy loss
stress
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2019-04-05
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized trial where women in an experimental arm will receive 3 times a three hour work shop with introduction to meditation and mindfulness during a 7 week period. Women in the other arm will have no intervention.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

1. Major Depression Index, 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).
2. Perceived Stress Scale, which 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).
3. The COMPI Fertility Problem Stress Scale, a validated scale measuring the impact of RPL on the woman and her interpersonal relationships.
4. The COMPI Marital Benefit Scale measuring if RPL has reinforced the couples mariage/relationship.

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.

Eligibility criteria: Inclusion Criteria:

* Women with RPL
* Speaking, reading and understanding Danish
* Have given a written consent
* Have a male partner
* Have a stress score \> 16 points on Perceived Stress Scale

Exclusion Criteria:

* If the patient is pregnant on inclusion day
* If the patient already is practing meditation and mindfulness
* If the patient has a depression
* If the patient develops a depression after inclusion in either arm

Primary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: 7 weeks
measure: Perceived Stress Scale (PSS)
timeFrame: 12 months
Secondary outcomes:
measure: COMPI Fertility Problem Stress Scale
timeFrame: 7 weeks
measure: Marital Benefit Scale
timeFrame: 7 weeks
measure: COMPI Fertility Problem Stress Scale
timeFrame: 12 months
measure: Marital Benefit
timeFrame: 12 months
measure: Major Depression Index (MDI)
timeFrame: 12 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Østerbro
Study officials:
affiliation: Rigshospitalet, Denmark
name: Karen Kirchheiner Jensen, Nurse
role: STUDY_DIRECTOR
References: