Investigation of Different Relaxation Techniques in Eliciting a Relaxation Response
|ClinicalTrials.gov Identifier: NCT03592147|
Recruitment Status : Completed
First Posted : July 19, 2018
Last Update Posted : July 19, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Stress, Psychological||Other: Guided Imagery Relaxation Tape Other: Music Listening Other: Relaxation Lighting Other: Meditation and Relaxation Light Other: Music and Relaxation Light Other: Control/Silence||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|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.|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||April 13, 2018|
|Actual Primary Completion Date :||June 4, 2018|
|Actual Study Completion Date :||June 4, 2018|
This 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.
Other: Guided Imagery Relaxation Tape
The meditation is approximately 7 minutes in duration.
Other Name: Mediation
Other: Music Listening
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.
Other Name: Music
Other: Relaxation Lighting
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.
Other: Meditation and Relaxation Light
The guided imagery meditation and relaxation lighting were combined.
Other: Music and Relaxation Light
The music 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.
- Perceived Relaxation [ Time Frame: Post-intervention, an average of 10 mins ]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).
- Blood Pressure [ Time Frame: Post-intervention, an average of 10 mins ]Systolic and diastolic blood pressure (mmHg) were measured three times using a digital sphygmomanometer.
- Heart Rate [ Time Frame: Post-intervention, an average of 10 mins ]Heart rate (bpm) was measured three times using a digital sphygmomanometer.
- Fingertip Temperature [ Time Frame: Post-intervention, an average of 10 mins ]A non-contact digital thermometer was used to measure fingertip temperature as an indication of sympathetic nervous system activation.
- Preference [ Time Frame: At the end of the study, at approximately 3-6 weeks ]The women were asked to rank the relaxation therapies in order of preference
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03592147
|University College London Great Ormond Street Institute of Child Health|
|London, United Kingdom, WC1N 1EH|