Meditation and Mindfulness for Recurrent Pregnancy Loss

NCT ID: NCT03905395

Last Updated: 2019-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-02
• Study Completion Date: 2020-06-30

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.

Conditions

Recurrent Pregnancy Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Meditation and mindfulness intervention

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.

Group Type: ACTIVE_COMPARATOR

Meditation and mindfulness

Intervention Type: BEHAVIORAL

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.

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Meditation and mindfulness

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 46 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Henriette Svarre Nielsen, MD, DMSc

OTHER

Sponsor Role: lead

Responsible Party

Henriette Svarre Nielsen, MD, DMSc

Henriette Svarre Nielsen, MD, DMSc, Consultant, Head of Recurrent Pregnancy Loss Unit, Associate Professor, Rigshospitalet, Denmark

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Karen Kirchheiner Jensen, Nurse

Role: STUDY_DIRECTOR

Rigshospitalet, Denmark

Locations

Rigshospitalet

Copenhagen, Østerbro, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Henriette Svarre Nielsen, MD, DMSc

Role: CONTACT

Henriette.Svarre.Nielsen@regionh.dk

+4535458486

Karen Henriette Kirchheiner Jensen, Nurse

Role: CONTACT

Karen.Henriette.jensen@regionh.dk

+4535458486

Facility Contacts

Henriette Svarre Nielsen, MD. MDSc

Role: primary

Henriette.Svarre.Nielsen@regionh.dk

+4535458486

Karen Kirchheiner Jensen, Nurse

Role: backup

Karen.Henriette.Jensen@regionh.dk

+4535458486

Other Identifiers

H-18038456

Identifier Type: -

Identifier Source: org_study_id