Investigation of Different Relaxation Techniques in Eliciting a Relaxation Response
Identification of the Most Effective Relaxation Tool for Use in a Trial to Improve Breastfeeding Outcomes in Mothers of Late Preterm Infants: a Pilot Study
1 other identifier
interventional
17
1 country
1
Brief Summary
While the stress response, characterised by an increase in heart rate, blood pressure, and cortisol, has evolved to ensure the survival of the organism in face of danger, chronic stress due to psychological stressors can be harmful. The opposite of the stress response is the "relaxation response". Mind-body techniques such as meditation, guided imagery and music therapy are thought to induce this response. The relaxation response is characterized as a wakeful hypometabolic state, where a decrease in central nervous system arousal is observed. Some studies reported a reduction in stress hormones, and in symptoms of anxiety and depression following the use of mind-body relaxation techniques. Other studies noted a reduction in stress measured using physiological measurements such as heart rate and blood pressure. Light therapy is another technique that is suggested to induce physiological changes similar to those seen in the relaxation response. Some studies have shown a reduction in heart rate, blood pressure, oxygen consumption and carbon dioxide production following exposure to blue light. These relaxation therapies can be useful for the general population and for vulnerable groups where alternative therapies, such as medication and psychotherapy, are difficult. Limited amount of studies have quantified the decrease in stress in physiological measurements such as heart rate and blood pressure. The aim of this study is to investigate which relaxation technique among five different interventions (and one control) is the most effective in improving relaxation and reducing stress in adult women of reproductive age (18-45 years). The results of this study will be used to inform the intervention of a study testing the impact of relaxation therapy on breastfeeding outcomes in mothers of late preterm infants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2018
CompletedFirst Submitted
Initial submission to the registry
July 5, 2018
CompletedFirst Posted
Study publicly available on registry
July 19, 2018
CompletedJuly 19, 2018
July 1, 2018
2 months
July 5, 2018
July 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Perceived Relaxation
Perceived relaxation was assessed using a visual analogue scale (VAS), which is a 10 cm horizontal line spanning from the minimum to the maximum of the variable measured. The minimum (left) represents "completely unrelaxed" and the maximum (right) "completely relaxed". The women mark a point on the scale to indicate their feelings of relaxation. The distance between the mark and the minimum point was measured in centimetres (two decimal points).
Post-intervention, an average of 10 mins
Blood Pressure
Systolic and diastolic blood pressure (mmHg) were measured three times using a digital sphygmomanometer.
Post-intervention, an average of 10 mins
Heart Rate
Heart rate (bpm) was measured three times using a digital sphygmomanometer.
Post-intervention, an average of 10 mins
Fingertip Temperature
A non-contact digital thermometer was used to measure fingertip temperature as an indication of sympathetic nervous system activation.
Post-intervention, an average of 10 mins
Secondary Outcomes (1)
Preference
At the end of the study, at approximately 3-6 weeks
Study Arms (1)
Relaxation
OTHERThis is a within-subject pilot study, where each participant received, in random order, five different relaxation therapies (Guided Imagery Relaxation Tape, Music Listening, Relaxation Lighting, Meditation and Relaxation Light, and Music and Relaxation Light) and one Control/Silence state spanning across 3-6 weeks.
Interventions
The meditation is approximately 7 minutes in duration.
Participants have the option of selecting one of the following music categories: New age, classical, and oriental. The songs were selected based on criteria established in a previous study to induce relaxation. All songs were also modified in length to be approximately 7 minutes in duration.
The participants were asked to select either orange or blue lighting settings using the Philips Hue lighting. The intensity of the light will be fixed to control for that measure. They were asked to sit for approximately 7 minutes in duration.
The guided imagery meditation and relaxation lighting were combined.
The participants were asked to relax for a duration of 7 minutes, with no explicit advice given. Lighting was adjusted to a specific intensity and colour (basic yellow light) as was used in the music and guided imagery interventions.
Eligibility Criteria
You may qualify if:
- Women of reproductive age (18-45 years)
- Fluent in English
You may not qualify if:
- Any condition that may affect blood pressure, heart rate or energy expenditure i.e hypertension, hyperthyroidism, heart failure
- Smokers
- Recent surgeries or injuries
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University College London Great Ormond Street Institute of Child Health
London, WC1N 1EH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2018
First Posted
July 19, 2018
Study Start
April 13, 2018
Primary Completion
June 4, 2018
Study Completion
June 4, 2018
Last Updated
July 19, 2018
Record last verified: 2018-07