A Prospective Study Investigating the Use of Relaxation Prior to Medical Procedures.

A Prospective Study Investigating the Use of Relaxation Prior to Medical Procedures

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02690194

Enrollment

Registered

2016-02-24

Start date

2015-08-31

Completion date

2017-01-10

Last updated

2018-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Pain

Keywords

Buddhify, Stress, Anxiety, Relaxation Technique

Brief summary

The primary aim is to investigate the efficacy of Buddhify relaxation therapy in reducing the stress and anxiety levels of patients. The secondary aim is to investigate the effect of prior stress and anxiety levels on the perceived pain level of undergoing a medical procedure, reported post-procedure.

Detailed description

Undergoing medical procedures is reported to cause stress and anxiety among many individuals.This can trigger the sympathetic nervous response, including decreased skin temperature, increased pulse, and increased blood pressure. While evolutionary advantageous, this response has deleterious effects on the healing process. Heightened stress levels can also trigger an increased release of cortisol, a naturally produced steroid hormone known to hinder the immune response. In response to high levels of stress, a patient's tolerance for pain decreases and the perceived pain level increases. Relaxation techniques can assist in reducing the stress and anxiety levels of a patient, which allows for lower perceived pain and more rapid healing. Many relaxation techniques exist, including acupuncture, child life intervention, breathing therapy and guided imagery. Buddhify, a mobile application, incorporates breathing therapy and audio-guided imagery into brief relaxation sessions, with the goal of reducing the stress and anxiety levels of the user. This application presents a convenient option for patients to use prior to undergoing a procedure. If proven to be effective, this application could be more widely used to help reduce the stress level, anxiety level and subsequent perceived pain level of patients, ultimately improving their healing reaction.

Interventions

DEVICEPlacebo Group

The placebo group will wear headphones and listen to nature sounds.

DEVICEBuddhify Therapy

The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

14 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients aged 14 and older undergoing an invasive procedure by Dr. Gianmichel Corrado at the Division of Sports Medicine of Boston Children's Hospital.

Design outcomes

Primary

Measure	Time frame	Description
Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure	Pre-therapy/pre-procedure	Pre-therapy/pre-procedure stress level measured by blood pressure in mmHg
Pre-therapy/Pre-procedure Stress Level Measured by Pulse	Pre-therapy/pre-procedure	Pre-therapy/pre-procedure stress level measured by pulse in beats per minute.
Pre-therapy/Pre-procedure Stress Level Measured by Respiratory Rate	Pre-therapy/pre-procedure	Pre-therapy/pre-procedure stress level measured by respiratory rate in breaths per minute.
Pre-therapy/Pre-procedure Anxiety Level	Pre-therapy/pre-procedure	Pre-therapy/pre-procedure anxiety level measure by the State-Trait Anxiety Inventory. The scale ranges from a minimum score of 40 to a maximum score of 160 with a higher score indicating higher levels of anxiety.

Secondary

Measure	Time frame	Description
Perceived Pain Level of the Procedure as Assessed by the Wong-Baker FACES Pain Rating Scale	Immediately post-procedure	Perceived pain level of the procedure as assessed by the Wong-Baker FACES pain rating scale 1-10. A score of 1 indicates no hurt (a better outcome) while a score of 10 indicates hurts worst (worst outcome).
Drink in Last Hour	Pre-therapy/Pre-procedure	Indication of if the patient has had a drink in the last hour
Eat in Last Hour	Pre-therapy/Pre-procedure	Indication of if the patient has eaten in the last hour
Post-therapy/Pre-procedure Change in Stress Level Measured by Pulse	Post-therapy/pre-procedure	Post-therapy/pre-procedure change in stress level measured by pulse in beats per minute. Value at prost-therapy/pre-procedure minus value at pre-therapy/pre-procedure.
Injection Experiences	Pre-therapy/Pre-procedure	Indication of prior injection experiences
Number of Injections	Pre-therapy/Pre-procedure	Average number of injections for patients that indicated that they previously have had injections
Exercise in Last Hour	Pre-therapy/Pre-procedure	Indication of if the patient has exercised in the last hour
Post-therapy/Pre-procedure Change in Stress Level Measured by Respiration Rate	Post-therapy/pre-procedure	Post-therapy/pre-procedure stress level measured by respiratory rate in breaths per minute. Value at post-therapy/pre-procedure minus value at pre-therapy/pre-procedure.
Post-therapy/Pre-procedure Change in Anxiety Level	Post-therapy/pre-procedure	Post-therapy/Pre-procedure change in anxiety level measure by the State-Trait Anxiety Inventory. Value at post-therapy/pre-procedure minus value at pre-therapy/pre-procedure. The scale ranges from a minimum score of 40 to a maximum score of 160 with a higher score indicating higher levels of anxiety.
Post-therapy/Pre-procedure Change in Stress Level Measured by Blood Pressure	Post-therapy/Pre-procedure	Post-therapy/pre-procedure change in stress level measured by blood pressure measured in mmHg. Value at post-therapy/pre-procedure minus value at pre-therapy/pre-procedure.

Countries

United States

Participant flow

Pre-assignment details

Control group data was not analyzed for all measures

Participants by arm

Arm	Count
Placebo Group 1. Pre-Placebo therapy * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. PLACEBO THERAPY SESSION 3. Post-Placebo therapy/Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 4. PROCEDURE 5. Post-procedure -Rate pain level of procedure Placebo Group: The placebo group will wear headphones and listen to nature sounds.	16
Experimental (Buddhify) Group 1. Pre-Buddhify therapy * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. BUDDHIFY THERAPY SESSION 3. Post-Buddhify therapy/Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 4. PROCEDURE 5. Post-procedure -Rate pain level of procedure Buddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.	14
Control Group 1. Pre-Procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. PROCEDURE 3. Post-procedure -Rate pain level of procedure	19
Total	49

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Withdrawal by Subject	1	4	0

Baseline characteristics

Characteristic	Placebo Group	Experimental (Buddhify) Group	Control Group	Total
Age, Categorical <=18 years	2 Participants	1 Participants	2 Participants	5 Participants
Age, Categorical >=65 years	3 Participants	5 Participants	7 Participants	15 Participants
Age, Categorical Between 18 and 65 years	11 Participants	8 Participants	10 Participants	29 Participants
Age, Continuous	50.9 years STANDARD_DEVIATION 18	53.9 years STANDARD_DEVIATION 15.8	55.5 years STANDARD_DEVIATION 17.1	52.4 years STANDARD_DEVIATION 2.12
Race and Ethnicity Not Collected	—	—	—	0 Participants
Sex: Female, Male Female	10 Participants	11 Participants	14 Participants	35 Participants
Sex: Female, Male Male	6 Participants	3 Participants	5 Participants	14 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 0	0 / 0	0 / 0
other Total, other adverse events	0 / 0	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0	0 / 0

Outcome results

Primary

Pre-therapy/Pre-procedure Anxiety Level

Pre-therapy/pre-procedure anxiety level measure by the State-Trait Anxiety Inventory. The scale ranges from a minimum score of 40 to a maximum score of 160 with a higher score indicating higher levels of anxiety.

Time frame: Pre-therapy/pre-procedure

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo Group	Pre-therapy/Pre-procedure Anxiety Level	S-Anxiety Score	33.1 score on a scale	Standard Deviation 7.2
Placebo Group	Pre-therapy/Pre-procedure Anxiety Level	T-Anxiety Score	35.6 score on a scale	Standard Deviation 6.1
Experimental (Buddhify) Group	Pre-therapy/Pre-procedure Anxiety Level	S-Anxiety Score	34.4 score on a scale	Standard Deviation 10.9
Experimental (Buddhify) Group	Pre-therapy/Pre-procedure Anxiety Level	T-Anxiety Score	34.0 score on a scale	Standard Deviation 7.6
Control Group	Pre-therapy/Pre-procedure Anxiety Level	S-Anxiety Score	31.4 score on a scale	Standard Deviation 7.1
Control Group	Pre-therapy/Pre-procedure Anxiety Level	T-Anxiety Score	32.4 score on a scale	Standard Deviation 9.4

Primary

Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure

Pre-therapy/pre-procedure stress level measured by blood pressure in mmHg

Time frame: Pre-therapy/pre-procedure

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo Group	Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure	BP-Systolic	121.9 mmHg	Standard Deviation 17.5
Placebo Group	Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure	BP-Diastolic	77.2 mmHg	Standard Deviation 10.8
Experimental (Buddhify) Group	Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure	BP-Systolic	121.9 mmHg	Standard Deviation 9.5
Experimental (Buddhify) Group	Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure	BP-Diastolic	78.9 mmHg	Standard Deviation 8.1
Control Group	Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure	BP-Systolic	127.3 mmHg	Standard Deviation 14.1
Control Group	Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure	BP-Diastolic	82.2 mmHg	Standard Deviation 11.3

Primary

Pre-therapy/Pre-procedure Stress Level Measured by Pulse

Pre-therapy/pre-procedure stress level measured by pulse in beats per minute.

Time frame: Pre-therapy/pre-procedure

Arm	Measure	Value (MEAN)	Dispersion
Placebo Group	Pre-therapy/Pre-procedure Stress Level Measured by Pulse	75.6 Beats per minute	Standard Deviation 14.3
Experimental (Buddhify) Group	Pre-therapy/Pre-procedure Stress Level Measured by Pulse	66.4 Beats per minute	Standard Deviation 14.4
Control Group	Pre-therapy/Pre-procedure Stress Level Measured by Pulse	69.5 Beats per minute	Standard Deviation 11.2

Primary

Pre-therapy/Pre-procedure Stress Level Measured by Respiratory Rate

Pre-therapy/pre-procedure stress level measured by respiratory rate in breaths per minute.

Time frame: Pre-therapy/pre-procedure

Arm	Measure	Value (MEAN)	Dispersion
Placebo Group	Pre-therapy/Pre-procedure Stress Level Measured by Respiratory Rate	16.1 Breaths per minute	Standard Deviation 3
Experimental (Buddhify) Group	Pre-therapy/Pre-procedure Stress Level Measured by Respiratory Rate	14.0 Breaths per minute	Standard Deviation 2.1
Control Group	Pre-therapy/Pre-procedure Stress Level Measured by Respiratory Rate	14.4 Breaths per minute	Standard Deviation 2.1

Secondary