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Investigation of Different Relaxation Techniques in Eliciting a Relaxation Response

Primary Purpose

Stress, Psychological

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Guided Imagery Relaxation Tape
Music Listening
Relaxation Lighting
Meditation and Relaxation Light
Music and Relaxation Light
Control/Silence
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress, Psychological focused on measuring Meditation, Music, Relaxation, Light Therapy, Stress

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University College London Great Ormond Street Institute of Child Health

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Relaxation

Arm Description

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.

Outcomes

Primary Outcome Measures

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).
Blood Pressure
Systolic and diastolic blood pressure (mmHg) were measured three times using a digital sphygmomanometer.
Heart Rate
Heart rate (bpm) was measured three times using a digital sphygmomanometer.
Fingertip Temperature
A non-contact digital thermometer was used to measure fingertip temperature as an indication of sympathetic nervous system activation.

Secondary Outcome Measures

Preference
The women were asked to rank the relaxation therapies in order of preference

Full Information

First Posted
July 5, 2018
Last Updated
July 18, 2018
Sponsor
University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT03592147
Brief Title
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 13, 2018 (Actual)
Primary Completion Date
June 4, 2018 (Actual)
Study Completion Date
June 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological
Keywords
Meditation, Music, Relaxation, Light Therapy, Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Relaxation
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Guided Imagery Relaxation Tape
Other Intervention Name(s)
Mediation
Intervention Description
The meditation is approximately 7 minutes in duration.
Intervention Type
Other
Intervention Name(s)
Music Listening
Other Intervention Name(s)
Music
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Relaxation Lighting
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Meditation and Relaxation Light
Intervention Description
The guided imagery meditation and relaxation lighting were combined.
Intervention Type
Other
Intervention Name(s)
Music and Relaxation Light
Intervention Description
The music and relaxation lighting were combined.
Intervention Type
Other
Intervention Name(s)
Control/Silence
Intervention Description
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 Measure Information:
Title
Perceived Relaxation
Description
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).
Time Frame
Post-intervention, an average of 10 mins
Title
Blood Pressure
Description
Systolic and diastolic blood pressure (mmHg) were measured three times using a digital sphygmomanometer.
Time Frame
Post-intervention, an average of 10 mins
Title
Heart Rate
Description
Heart rate (bpm) was measured three times using a digital sphygmomanometer.
Time Frame
Post-intervention, an average of 10 mins
Title
Fingertip Temperature
Description
A non-contact digital thermometer was used to measure fingertip temperature as an indication of sympathetic nervous system activation.
Time Frame
Post-intervention, an average of 10 mins
Secondary Outcome Measure Information:
Title
Preference
Description
The women were asked to rank the relaxation therapies in order of preference
Time Frame
At the end of the study, at approximately 3-6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University College London Great Ormond Street Institute of Child Health
City
London
ZIP/Postal Code
WC1N 1EH
Country
United Kingdom

12. IPD Sharing Statement

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Investigation of Different Relaxation Techniques in Eliciting a Relaxation Response

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