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

Boston Children's Hospital

Status: Completed

Conditions: Anxiety; Pain

Treatments: Device: Placebo Group; Device: Buddhify Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02690194

IRB-P00016464

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Exclusion Criteria:

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

54 participants in 3 patient groups, including a placebo group

Placebo Group

Placebo Comparator group

Description:

Pre-Placebo therapy Blood pressure, pulse, and respiration rate State-Trait Anxiety Inventory PLACEBO THERAPY SESSION Post-Placebo therapy/Pre-procedure Blood pressure, pulse, and respiration rate State-Trait Anxiety Inventory PROCEDURE Post-procedure -Rate pain level of procedure

Treatment:

Device: Placebo Group

Experimental (Buddhify) Group

Experimental group

Description:

Pre-Buddhify therapy Blood pressure, pulse, and respiration rate State-Trait Anxiety Inventory BUDDHIFY THERAPY SESSION Post-Buddhify therapy/Pre-procedure Blood pressure, pulse, and respiration rate State-Trait Anxiety Inventory PROCEDURE Post-procedure -Rate pain level of procedure

Treatment:

Device: Buddhify Therapy

Control Group

No Intervention group

Description:

Pre-Procedure Blood pressure, pulse, and respiration rate State-Trait Anxiety Inventory PROCEDURE Post-procedure -Rate pain level of procedure