NCT03593551

Brief Summary

This pilot study aims to find the most effective relaxation technique to help primiparous mothers who are breastfeeding their infant. The effect of five different relaxation techniques on physical and psychological changes in Chinese mothers will be investigated. The interventions to be used in this study include: guided relaxation meditation tape, music tape, relaxation lighting, combined relaxation meditation and lighting, and combined music and lighting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2018

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2018

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

25 days

First QC Date

July 10, 2018

Last Update Submit

July 23, 2018

Conditions

Stress-related ProblemBreastfeedingRelaxation TherapyPsychological Stress

Keywords

stressanxietybreastfeedingrelaxationmeditationmusic

Outcome Measures

Primary Outcomes (1)

  • Perceived relaxation

    Perceived relaxation measured by a visual analogue scale which consists of a horizontal 10cm line.The right anchor of the scale is identified as "completely relaxed" and the left anchor as"completely unrelaxed".

    3 minutes

Secondary Outcomes (3)

  • Fingertip temperature

    10 seconds

  • Heart rate

    2 minutes

  • Blood pressure

    2 minutes

Study Arms (1)

relaxation and control

EXPERIMENTAL

All participants will attend five relaxation treatments and one control. The order of treatments and control will be randomised allocated to participants.

Combination Product: five relaxation treatments and one control

Interventions

five relaxation treatments and one controlCOMBINATION_PRODUCT

Five treatments are relaxation meditation tape, music tape, relaxation lighting, meditation tape plus lighting, and music plus lighting. The control session have no intervention, participants will just be asked to sit comfortably for 10 minutes.

relaxation and control

Eligibility Criteria

Age23 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBiological sex is female (breastfeeding mothers)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • primiparous mothers who are currently breastfeeding their infants
  • generally healthy (without any diseases that could influence their blood pressure, heart rate, energy expenditure, or breastfeeding practice)
  • did not attend any other intervention studies within 12 months

You may not qualify if:

  • Smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Children Hospital

Beijing, 100045, China

Location

MeSH Terms

Conditions

Breast FeedingStress, PsychologicalAnxiety Disorders

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorBehavioral SymptomsMental Disorders

Study Officials

  • Mary Fewtrell, PhD

    University College, London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Masking Details
The order for five treatments and one control are randomly allocated to participants. Each participant will attend all six sessions (five treatments and one control)
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: within study design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Paediatric Nutrition

Study Record Dates

First Submitted

July 10, 2018

First Posted

July 20, 2018

Study Start

June 3, 2018

Primary Completion

June 28, 2018

Study Completion

June 28, 2018

Last Updated

July 26, 2018

Record last verified: 2018-07

Locations

CN(1)