Investigation of Different Relaxation Techniques in Eliciting a Relaxation Response

NCT ID: NCT03592147

Last Updated: 2018-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-13

Study Completion Date

2018-06-04

Brief Summary

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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.

Detailed Description

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Conditions

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Stress, Psychological

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Guided Imagery Relaxation Tape

Intervention Type OTHER

The meditation is approximately 7 minutes in duration.

Music Listening

Intervention Type OTHER

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.

Relaxation Lighting

Intervention Type OTHER

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.

Meditation and Relaxation Light

Intervention Type OTHER

The guided imagery meditation and relaxation lighting were combined.

Music and Relaxation Light

Intervention Type OTHER

The music and relaxation lighting were combined.

Control/Silence

Intervention Type OTHER

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.

Interventions

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Guided Imagery Relaxation Tape

The meditation is approximately 7 minutes in duration.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Meditation and Relaxation Light

The guided imagery meditation and relaxation lighting were combined.

Intervention Type OTHER

Music and Relaxation Light

The music and relaxation lighting were combined.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Mediation Music

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University College London Great Ormond Street Institute of Child Health

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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12521/001

Identifier Type: -

Identifier Source: org_study_id

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