The Effect of Mindfulness-Based Practices and Deep Relaxation Exercises in Pregnant Women

• Sponsor: Amasya University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05447000
• Collaborator: (none)
• Enrollment: 111
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 6
• Patients Per Site Per Month: 18.5

Study Details

Study Description

Brief Summary

Pregnancy is a transitional period during which important physical, biological and psychological changes are experienced for women, and the probability of encountering factors that may cause stress, anxiety and low quality of life is high. Maternal stress in pregnancy is associated with negative birth outcomes and can be reduced with relaxation exercises. However, mindfulness-based approaches affect pregnancy outcomes positively. A total of 111 pregnant women (37 mindfulness based stress reduction program, 37 deep relaxation exercises and 37 control) are planned to be included in the study. Data will be collected with the "Personal Description Form", and "The Pregnancy-related Anxiety Questionnaire-Revised 2".

Condition or Disease	Intervention/Treatment	Phase
Anxiety; Pregnancy Related	Behavioral: Mindfullness Based Stress Reduction (MBSR) intervention; Behavioral: Deep Relaxation Exercises intervention; Other: No Intervention	N/A

Detailed Description

Pregnancy is a transitional period during which important physical, biological and psychological changes are experienced for women, and the probability of encountering factors that may cause stress, anxiety and low quality of life is high. Maternal stress in pregnancy is associated with negative birth outcomes and can be reduced with relaxation exercises. However, mindfulness-based approaches affect pregnancy outcomes positively. The aim of this study, which was conducted to determine the effects of mindfulness practices and deep relaxation exercises on the level of pregnancy-related anxiety, is to create intervention programs compatible with the prenatal period and to contribute to the improvement of pregnancy outcomes. A total of 111 pregnant women (37 mindfulness based stress reduction program, 37 deep relaxation exercises and 37 control) are planned to be included in the study. Data will be collected with the "Personal Description Form", and "The Pregnancy-related Anxiety Questionnaire-Revised 2". mindfulness and deep relaxation practices will be applied by midwives who are experts in their fields who are certified in these fields.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 111 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Effect of Mindfulness-Based Practices and Deep Relaxation Exercises on Pregnancy-Related Anxiety Level
• Anticipated Study Start Date: Jul 2, 2022
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mindfullness Based Stress Reduction Mindfullness Based Stress Reduction (MBSR) therapy	Behavioral: Mindfullness Based Stress Reduction (MBSR) intervention; Mindfullness Based Stress Reduction (MBSR) intervention: Monitoring anxiety levels with mindfulness program
Experimental: Deep Relaxation Exercises Deep Relaxation Exercises therapy	Behavioral: Deep Relaxation Exercises intervention; Deep Relaxation Exercises intervention: Monitoring anxiety levels with deep Relaxation Exercises intervention
Other: Control Control	Other: No Intervention; No Intervention

Outcome Measures

Primary Outcome Measures

1. Pregnancy-Related Anxiety Scale [At the end of the 1 months]

   For primiparas, a minimum of 11 points and a maximum of 55 points is obtained, and for multipars, a minimum of 10 and a maximum of 50 points are obtained. As the score obtained from the scale increases, it is accepted that the level of anxiety in pregnancy is higher.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Having internet access,

• Without any diagnosed psychiatric health problem,

• At 10-28 weeks of gestation,

• There is no risk factor in pregnancy,

• Literate,

• Using smart phone,

• Having a headset accessory for phone calls,

• Pregnant women who voluntarily agreed to participate in the study

Exclusion Criteria:

-Mental disabilities

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Amasya University	Amasya		Turkey	05000

Sponsors and Collaborators

• Amasya University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Emine Akca, Assist. Prof. Dr. in the Amasya University Midwifery Department, Amasya University
• ClinicalTrials.gov Identifier: NCT05447000
• Other Study ID Numbers: Amasya University
• First Posted: Jul 7, 2022
• Last Update Posted: Jul 7, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

No Results Posted as of Jul 7, 2022