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Completed

NCT Number: NCT03592147

Investigation of Different Relaxation Techniques in Eliciting a Relaxation Response

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University College London Great Ormond Street Institute of Child Health

London, WC1N 1EH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Guided Imagery Relaxation Tape

Other

The meditation is approximately 7 minutes in duration.

Other names: Mediation

Music listening

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.

Other names: Music

Relaxation Lighting

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

Other

The guided imagery meditation and relaxation lighting were combined.

Music and Relaxation Light

Other

The music and relaxation lighting were combined.

Control/Silence

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 19, 2018
Registry last updated
Jul 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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