Meditation and Mindfulness for Recurrent Pregnancy Loss

NCT03905395 | Unknown

• 1 other identifier: H-18038456
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Pregnancy Loss

Keywords

Meditation; mindfulness; pregnancy loss; stress

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 months

Secondary Outcomes (5)

• COMPI Fertility Problem Stress Scale

  7 weeks

• Marital Benefit Scale

  7 weeks

• COMPI Fertility Problem Stress Scale

  12 months

• Marital Benefit

  12 months

• Major Depression Index (MDI)

  12 months

Study Arms (2)

Meditation and mindfulness intervention

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

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.

Interventions

Meditation and mindfulness 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.

Meditation and mindfulness intervention

Eligibility Criteria

• Age: 18 Years - 46 Years
• Gender Eligibility Details: Based on biological sex
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• If the patient already is practing meditation and mindfulness
• If the patient has a depression

Sponsors & Collaborators

• Henriette Svarre Nielsen, MD, DMSc: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Østerbro, 2100, Denmark

RECRUITING

MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Karen Kirchheiner Jensen, Nurse

  Rigshospitalet, Denmark

  STUDY DIRECTOR

Central Study Contacts

Henriette Svarre Nielsen, MD, DMSc

CONTACT

+4535458486; Henriette.Svarre.Nielsen@regionh.dk

Karen Henriette Kirchheiner Jensen, Nurse

CONTACT

+4535458486; Karen.Henriette.jensen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Henriette Svarre Nielsen, MD, DMSc, Consultant, Head of Recurrent Pregnancy Loss Unit, Associate Professor, Rigshospitalet, Denmark

Model Details: 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.

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 5, 2019
• Study Start: February 2, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: April 5, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)