Investigation of Different Relaxation Techniques in Eliciting a Relaxation Response

Stress, Psychological Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03592147
• Other study ID #: 12521/001
• Status: Completed
• Phase: N/A
• Start date: April 13, 2018
• Est. completion date: June 4, 2018

Study information

• Verified date: July 2018
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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". 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 4, 2018
• Est. primary completion date: June 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress, Psychological

Intervention

Other:
• Guided Imagery Relaxation Tape
The meditation is approximately 7 minutes in duration.
• 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.
• 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.
• Meditation and Relaxation Light
The guided imagery meditation and relaxation lighting were combined.
• Music and Relaxation Light
The music and relaxation lighting were combined.
• 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.

Locations

Country	Name	City	State
United Kingdom	University College London Great Ormond Street Institute of Child Health	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Post-intervention, an average of 10 mins
Primary	Blood Pressure	Systolic and diastolic blood pressure (mmHg) were measured three times using a digital sphygmomanometer.	Post-intervention, an average of 10 mins
Primary	Heart Rate	Heart rate (bpm) was measured three times using a digital sphygmomanometer.	Post-intervention, an average of 10 mins
Primary	Fingertip Temperature	A non-contact digital thermometer was used to measure fingertip temperature as an indication of sympathetic nervous system activation.	Post-intervention, an average of 10 mins
Secondary	Preference	The women were asked to rank the relaxation therapies in order of preference	At the end of the study, at approximately 3-6 weeks