Effects of Different Relaxation Interventions on Reducing Stress in Chinese Breastfeeding Mothers
Condition: Stress-related Problem; Breastfeeding; Relaxation Therapy; Psychological Stress
MeSH terms: Stress, Psychological
Study type: Interventional

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.
    

Intervention name(s): five relaxation treatments and one control
Intervention type(s): Combination Product
Intervention description(s): 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.
Intervention model: Sequential Assignment
Intervention model description: within study design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stress; anxiety; breastfeeding; relaxation; meditation; music