Effects of Different Relaxation Interventions on Reducing Stress in Chinese Breastfeeding Mothers
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|ClinicalTrials.gov Identifier: NCT03593551|
Recruitment Status : Completed
First Posted : July 20, 2018
Last Update Posted : July 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stress-related Problem Breastfeeding Relaxation Therapy Psychological Stress||Combination Product: five relaxation treatments and one control||Not Applicable|
|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)|
|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|
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.
- 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".
- 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).
- Heart rate [ Time Frame: 2 minutes ]Heart rate measured by electronic blood pressure machine. A lower heart rate indicates greater relaxation.
- Blood pressure [ Time Frame: 2 minutes ]Systolic and diastolic pressure measured by electronic blood pressure machine. A lower BP indicates greater relaxation.
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
|Beijing Children Hospital|
|Beijing, China, 100045|
|Principal Investigator:||Mary Fewtrell, PhD||University College, London|