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Investigation of Different Relaxation Techniques in Eliciting a Relaxation Response

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ClinicalTrials.gov Identifier: NCT03592147
Recruitment Status : Completed
First Posted : July 19, 2018
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
University College, London

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.


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

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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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stress

Arm Intervention/treatment
Relaxation
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.

Other: Control/Silence
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.




Primary Outcome Measures :
  1. 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).

  2. 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.

  3. Heart Rate [ Time Frame: Post-intervention, an average of 10 mins ]
    Heart rate (bpm) was measured three times using a digital sphygmomanometer.

  4. 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.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03592147


Locations
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United Kingdom
University College London Great Ormond Street Institute of Child Health
London, United Kingdom, WC1N 1EH
Sponsors and Collaborators
University College, London

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03592147     History of Changes
Other Study ID Numbers: 12521/001
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University College, London:
Meditation
Music
Relaxation
Light Therapy
Stress
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms