Clinical trial NCT03592147: Investigation of Different Relaxation Techniques in Eliciting a Relaxation Response
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Keywords: Meditation
Music
Relaxation
Light Therapy
Stress
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Within-subject pilot study, where each participant will undergo five different relaxation therapies (guided imagery meditation, music listening, "relaxation" lighting, combination of light and meditation, and a combination of light and music) and one silence/control state.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Women of reproductive age (18-45 years)
* Fluent in English

Exclusion Criteria:

* Any condition that may affect blood pressure, heart rate or energy expenditure i.e hypertension, hyperthyroidism, heart failure
* Smokers
* Recent surgeries or injuries

Primary outcomes:
measure: Perceived Relaxation
timeFrame: Post-intervention, an average of 10 mins
measure: Blood Pressure
timeFrame: Post-intervention, an average of 10 mins
measure: Heart Rate
timeFrame: Post-intervention, an average of 10 mins
measure: Fingertip Temperature
timeFrame: Post-intervention, an average of 10 mins
Secondary outcomes:
measure: Preference
timeFrame: At the end of the study, at approximately 3-6 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Great Ormond Street Institute of Child Health
Study officials:
References: