Health TrialsbyHealthPanel

Mindfulness in High Risk Pregnancies

ConditionsStressAnxietyDepressionMindfulness
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Alberta

About this trial

Anxiety, depression and stress are common during pregnancy. These have been found to negatively impact mother and child outcomes. When anxiety, depression, and stress are present in pregnant women, it is therefore important to manage them to improve the outcome of the mother and her child.

Although pregnancy itself has been shown to increase anxiety, depression and stress, these issues are further elevated in high-risk pregnancy groups. Mothers at risk of preterm delivery (less than 37 weeks gestational age), have been found to have higher rates of depression, anxiety and stress compared to uncomplicated term pregnancies. In addition, anxiety, depression and stress symptoms themselves increase the risk for preterm delivery, creating a vicious cycle for this high-risk group.

Mindfulness is a tool that has been during pregnancy to reduce depression, anxiety, and stress. Many studies have found mindfulness to be an appropriate management option in normal term pregnancies.

To date, there have been no studies that have looked at Mindfulness as a tool for mothers admitted due to risk of preterm delivery. This study will explore the impact of teaching mindfulness skills to inpatient mothers at risk of preterm delivery and studying its effects on maternal depression, anxiety, and stress.

This study involves providing Mindfulness strategies during the mother's inpatient admission for the risk of preterm delivery 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 mindfulness on anxiety, depression and stress. The participants will also be encouraged to maintain a weekly mindfulness log. The results of this research may lead to future studies looking at the impact of mindfulness practice for high-risk pregnancies. This will also help open up the possibility of offering such courses for inpatient and outpatient high-risk pregnancies in the future.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pregnant mothers admitted to the antepartum ward at the Lois Hole Hospital for risk of preterm delivery (< 34 weeks GA) are eligible for the study.

if they speak, read and write English,

if their inpatient stay is anticipated to be at least 4 weeks following recruitment

if they are willing and able to attend the mindfulness sessions.

Disqualifiers

if they are experiencing current mental illness issues

if they are experiencing current or prior substance abuse

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mindfulness

    Behavioral

    Mindfulness training

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Mindfulness InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in stress symptoms

using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of stress symptoms. Minimum score is 0. Maximum score is 21.

Time frame
Change from recruitment to 4 weeks after
2

Change in anxiety symptoms

using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). Minimum score is 0. Maximum score is 21. And using the Pregnancy Related Anxiety Scale. Scores for individual question range from 1 (Not at all) to 5 (Very much). Minimum score is 10. Maximum score is 50. A high score in both scales means a high level of anxiety symptoms.

Time frame
Change from recruitment to 4 weeks after
3

Change in depression symptoms

using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of depression symptoms. Minimum score is 0. Maximum score is 21.

Time frame
Change from recruitment to 4 weeks after
4

Change in mindful awareness

using the Mindfulness Attention Awareness Scale. Scores for individual question range from 1 (Almost Never) to 6 (Almost Always). Minimum score is 15. Maximum score is 90. And using Toronto Mindfulness Scale. Scores for individual question range from 0 (Not at all) to 4 (Very much). This scale has 2 subscales. Minimum score is 0. Maximum score is 24 for the first subscale and 28 for the second subscale. A high score in both scales (and subscales)means a high mindful awareness level.

Time frame
Change from recruitment to 4 weeks after

Secondary outcomes

1

Mindfulness practice

Duration of mindfulness practice

Time frame
4 weeks
2

Gestational age

Gestational age of the newborn (in weeks and days) at the time of delivery

Time frame
variable (less than 20 weeks from recruitment)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: