Investigation of Different Relaxation Interventions on Physical and Psychological Changes in Breastfeeding Mothers in China: A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University College, London
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Perceived relaxation
Study Overview
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.
Detailed Description
The study will be conducted at Beijing Children Hospital, Beijing, China. A within-subject design will be used to evaluate the effectiveness and participants' feeling towards the five tested interventions compared to a control situation.
Population and recruitment The study population will be breastfeeding women in China. Recruitment will be take place through social media and community flyers in Beijing Children Hospital. Advertisements will be posted in the hospital while flyers will be sent to local communities. Interested women can make contact by email. Details about the study will be explained in the information sheet. After checking the eligibility and obtaining written informed consent, all eligible participants will be enrolled in the study.
Sample size calculation
To estimate the sample size of this pilot study, standard formulas used for calculation are:
Sample size (per equal-sized group) =8 x standard deviation ÷ (difference) 2
Study Design
- Study Type
- Interventional
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
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)
Eligibility Criteria
- Ages
- 23 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
- Not provided
Arms & Interventions
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.
Intervention: five relaxation treatments and one control (Combination Product)
Outcomes
Primary Outcomes
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 Outcomes
- Fingertip temperature(10 seconds)
- Blood pressure(2 minutes)
- Heart rate(2 minutes)
Investigators
Mary Fewtrell
Professor of Paediatric Nutrition
University College, London