Stress, PsychologicalNCT03592147
Investigation of Different Relaxation Techniques in Eliciting a Relaxation Response
A study testing Guided Imagery Relaxation Tape, Music Listening and Relaxation Lighting in people with Stress, Psychological, run by University College, London at 1 site in United Kingdom.
Trial 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". Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Guided Imagery Relaxation Tape, Music Listening and Relaxation Lighting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Apr 2018to 4 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women of reproductive age (18-45 years)
- Fluent in English
Who cannot join
- Any condition that may affect blood pressure, heart rate or energy expenditure i.e hypertension, hyperthyroidism, heart failure
- Smokers
- Recent surgeries or injuries
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University College London Great Ormond Street Institute of Child Health
London, WC1N 1EH
About this study
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
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.
Read more
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.
- Conditions
- Stress, Psychological
- Being tested
- Guided Imagery Relaxation Tape, Music Listening, Relaxation Lighting, Meditation and Relaxation Light, Music and Relaxation Light
- Keywords
- Meditation, Music, Relaxation, Light Therapy, Stress
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Imagery Relaxation TapeOther
Also called Mediation
The meditation is approximately 7 minutes in duration.
Music ListeningOther
Also called Music
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 LightingOther
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 LightOther
The guided imagery meditation and relaxation lighting were combined.
Music and Relaxation LightOther
The music and relaxation lighting were combined.
Control/SilenceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Relaxation | Other | 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. Receives: Other: Guided Imagery Relaxation Tape; Other: Music Listening; Other: Relaxation Lighting; Other: Meditation and Relaxation Light; Other: Music and Relaxation Light; Other: Control/Silence |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Post-intervention, an average of 10 mins
Blood Pressure
Systolic and diastolic blood pressure (mmHg) were measured three times using a digital sphygmomanometer.
Measured: Post-intervention, an average of 10 mins
Heart Rate
Heart rate (bpm) was measured three times using a digital sphygmomanometer.
Measured: Post-intervention, an average of 10 mins
Fingertip Temperature
A non-contact digital thermometer was used to measure fingertip temperature as an indication of sympathetic nervous system activation.
Measured: Post-intervention, an average of 10 mins
Secondary outcomes (1)
Preference
The women were asked to rank the relaxation therapies in order of preference
Measured: At the end of the study, at approximately 3-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start13 Apr 2018
- Primary completion4 Jun 2018
- Study completion4 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592147
- Sponsor's protocol ID
- 12521/001
- Status last verified
- Jul 2018
- First submitted
- 5 Jul 2018
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03592147
- Acronym / sponsor ID
- 12521/001
- Conditions
- Stress, Psychological
- Keywords
- Meditation, Music, Relaxation, Light Therapy, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 13 Apr 2018 (actual)
- Primary completion
- 4 Jun 2018 (actual)
- Study completion
- 4 Jun 2018 (actual)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Relaxation | Other | Other: Guided Imagery Relaxation Tape, Other: Music Listening, Other: Relaxation Lighting, Other: Meditation and Relaxation Light, Other: Music and Relaxation Light, Other: Control/SilenceThis 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women of reproductive age (18-45 years)
- Fluent in English
Key exclusion criteria (3 listed)
- Any condition that may affect blood pressure, heart rate or energy expenditure i.e hypertension, hyperthyroidism, heart failure
- Smokers
- Recent surgeries or injuries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided Imagery Relaxation TapeAlso: MediationThe meditation is approximately 7 minutes in duration. | Other | Relaxation |
| Music ListeningAlso: MusicParticipants 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 | Relaxation |
| Relaxation LightingThe 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 | Relaxation |
| Meditation and Relaxation LightThe guided imagery meditation and relaxation lighting were combined. | Other | Relaxation |
| Music and Relaxation LightThe music and relaxation lighting were combined. | Other | Relaxation |
| Control/SilenceThe 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. | Other | Relaxation |
Primary outcome
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.
1 secondary outcome
Preference
Time frame: At the end of the study, at approximately 3-6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Imagery Relaxation Tape, Music Listening and Relaxation Lighting in people with Stress, Psychological, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Relaxation (time frame: Post-intervention, an average of 10 mins). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2018.