Mindful Kangaroo Care: Mindfulness Intervention for Mothers During Skin-to-skin Care

NCT04696770 | Completed

• 1 other identifier: Pro00089053
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Very high levels of stress have been reported in parents with their infants admitted to Neonatal Intensive Care Unit (NICU). Review of literature shows that the symptoms are consistent with Post-Traumatic Stress Disorder (PTSD), Acute Stress Disorder and many parents have depression that lasts longer than a month. Skin-to-skin care offers many benefits to the mother and the infant including reduction of maternal stress. However, it has been observed that mothers giving skin-to-skin care for preterm infants in an NICU environment focus on the cardiorespiratory monitoring and its alarms instead of focusing on the baby and "being in the moment". There have also been other challenges noted with maternal sleep while providing skin-to-skin and parental distraction on hand-held devices while providing skin-to-skin. Mindfulness offers a way to focus on being in the moment and accepting the present moment in a non-judgmental and compassionate manner. Mindfulness has been shown to reduce stress in parents of babies admitted to NICU. To date, they are no studies looking at Mindfulness during skin-to-skin care. This study will explore the feasibility and acceptability of teaching mindfulness skills to mothers providing skin-to-skin care and studying its effects on maternal stress and distraction. This study involves providing Mindfulness-based strategies during skin-to-skin care to NICU mothers for four consecutive weeks. Participants will be enrolled through informed consent. All participants will be given pre and post participation questionnaires to examine the impact of the sessions on stress reduction, mental wellness and mindfulness quotient. The participants will also be encouraged to maintain a weekly kangaroo care log. Participants will be asked to fill out an acceptability form at the end of the 4 weeks. The data will be analyzed to study the effect of mindfulness on stress reduction and mental wellness. The study will also help understand the uptake and acceptance of such a course by NICU mothers. The results of this study will lead to a future randomized controlled trial looking at the impact of mindfulness practise during skin-to-skin care on parental stress reduction.

Conditions

Stress; Anxiety; Depression

Outcome Measures

Primary Outcomes (4)

• Change in stress symptoms

  Using the Parental Stressor Scale for NICU parents. Parents rate the amount of stress. Scores for each question range from 1 (not at all stressful) to 5 (extremely stressful). A higher score indicates a higher level of stress.

  Change from recruitment to 4 weeks after

• Change in anxiety symptoms

  Using the Patient Health Questionnaire 4. Scores for each question range from 1 (not at all) to 4 (nearly every day). A higher score suggests anxiety.

  Change from recruitment to 4 weeks after

• Change in depression symptoms

  Using the Patient Health Questionnaire 4. Scores for each question range from 1 (not at all) to 4 (nearly every day). A higher score suggests depression.

  Change from recruitment to 4 weeks after

• Acceptability

  A researcher created 3-point Likert scale, measuring acceptability of the different instruments and mindfulness intervention during the research project

  4 weeks after recruitment

Study Arms (2)

Mindfulness Intervention

EXPERIMENTAL

Four face-to-face direct coachings on Mindfulness technique at weekly intervals. The following will be the broad theme of each coaching session Week 1 - On the first encounter, the mothers will learn how to practice an introductory mindfulness technique to develop the awareness of any sensations felt in the body while holding their baby. Week 2 - On the second encounter, the mothers will learn how to practice a second mindfulness technique to create positive feelings in the body while holding their baby. During the third and fourth weekly encounters, the mothers will have a chance to ask their questions and explore further both mindfulness techniques as needed.

Behavioral: Mindfulness

Control

NO INTERVENTION

Standard of care will be offered to all mothers in the control group which includes kangaroo care but does not involve any mindfulness practices.

Interventions

Mindfulness BEHAVIORAL

Mindfulness techniques will be taught to the participants

Mindfulness Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Mothers would be eligible to participate
• if they speak, read and write English,
• if their baby is anticipated to require a NICU stay of at least 4 weeks following recruitment,
• if the baby's medical condition allows for skin-to-skin care at recruitment,
• if the mother is available to do regular kangaroo care during the next 4 weeks after recruitment and
• if the mother is agreeable to receive some teaching for 30-45 minutes weekly during those four weeks.

You may not qualify if:

• Mothers whose baby is experiencing imminent risk of death at recruitment will be excluded.
• Mothers who reported current mental illness issues, current or prior substance abuse/addiction will be excluded.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Royal Alexandra Hospital, NICU

Edmonton, Alberta, T5H3V9, Canada

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Marc-Antoine Landry, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 6, 2021
• Study Start: April 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: January 7, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)