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Effects of Different Relaxation Interventions on Reducing Stress in Chinese Breastfeeding Mothers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03593551
Recruitment Status : Completed
First Posted : July 20, 2018
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Mary Fewtrell, University College, London

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.

Condition or disease Intervention/treatment Phase
Stress-related Problem Breastfeeding Relaxation Therapy Psychological Stress Combination Product: five relaxation treatments and one control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Sequential Assignment
Intervention Model Description: within study design
Masking: None (Open Label)
Masking Description: 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)
Primary Purpose: Treatment
Official Title: Investigation of Different Relaxation Interventions on Physical and Psychological Changes in Breastfeeding Mothers in China: A Pilot Study
Actual Study Start Date : June 3, 2018
Actual Primary Completion Date : June 28, 2018
Actual Study Completion Date : June 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
Experimental: relaxation and control
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
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.




Primary Outcome Measures :
  1. Perceived relaxation [ Time Frame: 3 minutes ]
    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".


Secondary Outcome Measures :
  1. Fingertip temperature [ Time Frame: 10 seconds ]
    Fingertip temperature measured by Digital Body Thermometer in degrees centigrade. (A higher temperature is an indication of greater relaxation).

  2. Heart rate [ Time Frame: 2 minutes ]
    Heart rate measured by electronic blood pressure machine. A lower heart rate indicates greater relaxation.

  3. Blood pressure [ Time Frame: 2 minutes ]
    Systolic and diastolic pressure measured by electronic blood pressure machine. A lower BP indicates greater relaxation.



Information from the National Library of Medicine

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Ages Eligible for Study:   23 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Biological sex is female (breastfeeding mothers)
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Smoker

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03593551


Locations
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China
Beijing Children Hospital
Beijing, China, 100045
Sponsors and Collaborators
University College, London
Investigators
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Principal Investigator: Mary Fewtrell, PhD University College, London
  Study Documents (Full-Text)

Documents provided by Mary Fewtrell, University College, London:
Study Protocol  [PDF] July 18, 2018

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Responsible Party: Mary Fewtrell, Professor of Paediatric Nutrition, University College, London
ClinicalTrials.gov Identifier: NCT03593551    
Other Study ID Numbers: 12681/001
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mary Fewtrell, University College, London:
stress
anxiety
breastfeeding
relaxation
meditation
music
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms