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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

Tracking Information
First Submitted Date  ICMJE July 10, 2018
First Posted Date  ICMJE July 20, 2018
Last Update Posted Date July 26, 2018
Actual Study Start Date  ICMJE June 3, 2018
Actual Primary Completion Date June 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
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".
Original Primary Outcome Measures  ICMJE
 (submitted: July 10, 2018)
  • Blood pressure [ Time Frame: 2 minutes ]
    Systolic and diastolic pressure measured by electronic blood pressure machine
  • Heart rate [ Time Frame: 2 minutes ]
    Heart rate measured by electronic blood pressure machine
  • Fingertip temprature [ Time Frame: 10 seconds ]
    Fingertip temprature measured by Digital Body Thermometer
  • 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 was identified as "completely relaxed" and the left anchor was labeled "completely unrelaxed".
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Different Relaxation Interventions on Reducing Stress in Chinese Breastfeeding Mothers
Official Title  ICMJE Investigation of Different Relaxation Interventions on Physical and Psychological Changes in Breastfeeding Mothers in China: A Pilot Study
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

Here the effect size and standard deviation (SD) are estimated from a previous research, which evaluated the effect of audio-visual imagery on patient anxiety and physiological parameters. A sample of 51 patients was able to demonstrate a significant reduction in HR (mean change (Z)= -0.75, SD= 1.00; p=0.01). Accordingly, the estimated sample size (per equal-sized group) would be 28. However, since the present study will use a within-subject design, a sample of 14 participants will likely be able to demonstrate changes. Considering the potential drop-out rates, a total of 15-20 subjects will be enrolled in this study.

Study Procedures After obtaining informed consent, all participants enrolled in this study will be asked to attend for 30 minutes once to three times per week for five relaxation treatments and one control treatment (no intervention). The emotions and feelings of participants in both intervention and control treatment will be assessed before and after each treatment or control.

The duration of this study is six weeks. In order to fit with the subject's schedule and control the circadian rhythm, all treatments and control sessions will take place on different days each week. Each participant can choose a 30-minute time slot to fit participants' timetable. To make the outcome assessment more consistent, participants are encouraged to come at the same time of the day they chose. The order of interventions will be randomly assigned for each participant. Both relaxation interventions and control will be conducted in the breastfeeding room located at Beijing Children Hospital. This room is private, quiet and has comfy seating. Participants will be asked to leave their personal belongings, including any electronic devices, books and magazines, and personal work, during the experiment period.

Outcome measurements Primary outcomes of this study will be perceived relaxation level. Secondary outcomes are heart rate (HR), blood pressure (BP) and fingertip temperature (FT).

The HR, BP and FT will be measured at both the start and the end of the experiment. An automatic BP machine will be used for the measurements of HR and BP. The BP will be measured three times and the mean of three will be calculated and recorded. A thermometer will be used for the FT measurement.

The perceived relaxation will be assessed by a visual analogue scale (VAS), which consists of a horizontal 10cm line with one end representing the maximum and the other end the minimum of the variable to be measured. The right anchor of the scale is labelled as "completely relaxed" and the left anchor as "completely unrelaxed". Participants indicate their state of relaxation by marking a point along the line before each session and again at the end of each session. The distance from the left anchor to the mark made by participants is measured in millimeters and pre and post-test differences are compared.

Statistical analysis Data will be analysed using SPSS 24.0. Paired t-test will be used to detect changes in each of the primary outcomes before and after the treatment. One-way ANOVA will be conducted to find differences between control and each intervention group. Post-hoc analysis will be used to compare the effectiveness of each treatment. Differences will be considered statistically significant at p<0.05.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Stress-related Problem
  • Breastfeeding
  • Relaxation Therapy
  • Psychological Stress
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Combination Product: five relaxation treatments and one control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2018)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 28, 2018
Actual Primary Completion Date June 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Biological sex is female (breastfeeding mothers)
Ages  ICMJE 23 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03593551
Other Study ID Numbers  ICMJE 12681/001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mary Fewtrell, University College, London
Study Sponsor  ICMJE University College, London
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mary Fewtrell, PhD University College, London
PRS Account University College, London
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP