Diaphragmatic Breathing Training on Postpartum Anxiety

NCT05474248 | Unknown DMC

• 1 other identifier: TCRD-TPE-110-61
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

This is a two-group pretest-posttest, triple-blinded and randomized controlled trial examining the effects of a biofeedback-assisted diaphragmatic breathing training on postpartum anxiety. This study will include full-term postpartum women, aged from 20 to 49, who experienced anxious symptoms with State Anxiety Inventory (A-State) scored 40 or more at the first postpartum day. Participants will be randomly assigned to either an experimental group (n = 64) or a control group (n = 64). The experimental group will undergo the diaphragmatic breathing training assisted with StressEraser to breath slowly 4-6 times per minute and practice 15 minutes twice daily. Participants in the control condition receive postpartum usual care. The outcome measures include anxiety measured by State-Trait Anxiety Inventory (STAI) and the physiological parameters expressed by blood pressure (BP) and heart rate (HR). Measurements will be taken at the first postpartum day and one month postpartum. We except this breathing training design is able to improve women's postpartum anxiety, and in turn improve their physio-psychological health, breastfeeding and baby care skills.

Conditions

Postpartum Anxiety

Keywords

postpartum anxiety; biofeedback; diaphragmatic breathing

Outcome Measures

Primary Outcomes (2)

• Postpartum anxiety

  Assessments using the State-Trait Anxiety Inventory-State (STAI-S) for self-reported anxiety symptoms

  Baseline: postpartum day 1-3

• Postpartum anxiety

  Assessments using the State-Trait Anxiety Inventory-State (STAI-S) for self-reported anxiety symptoms

  Post-test: Change from baseline postpartum anxiety at 4 weeks postpartum

Secondary Outcomes (4)

• Heart rate

  Baseline: postpartum day 1-3

• Heart rate

  Post-test: Change from baseline heart rate at 4 weeks postpartum

• Blood pressure

  Baseline: postpartum day 1-3

• Blood pressure

  Post-test: Change from baseline heart rate at 4 weeks postpartum

Study Arms (2)

Diaphragmatic Breathing Training

EXPERIMENTAL

The experimental group will undergo the diaphragmatic breathing training assisted with StressEraser to breath slowly 4-6 times per minute and practice 15 minutes twice daily.

Behavioral: Experimental group

Control group

NO INTERVENTION

Usual care

Interventions

Experimental group BEHAVIORAL

Diaphragmatic Breathing Training

Diaphragmatic Breathing Training

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• full-term postpartum women
• aged from 20 to 49
• STAI-S scored 40 or more at the first postpartum day

You may not qualify if:

• newborn with severe illness or stillbirth
• maternal suicide or self-harm
• drug use: sedatives, hypnotics or antipsychotic drugs

Sponsors & Collaborators

• Ministry of Science and Technology, Taiwan: lead
• Taichung Tzu Chi Hospital: collaborator

Study Sites (1)

Taipei Tzu Chi Hospital

Taipei, Xindian Dist, 231405, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: July 26, 2022
• Study Start: February 28, 2021
• Primary Completion: April 12, 2021
• Study Completion: December 31, 2022
• Last Updated: July 26, 2022

Record last verified: 2022-07

Locations

TW (1)