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PainNCT02690194

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

A study testing Buddhify Therapy in people with Pain and Anxiety, run by Boston Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 years and older
Conditions the study is for
Pain, Anxiety
What is being tested?
Buddhify Therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
54 participants
Where
1 siteUnited States
Study dates
Aug 2015to 10 Jan 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 14 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Boston Childrens Hospital - Sports Medicine

    Boston, Massachusetts, 02115

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Pain, Anxiety
Being tested
Placebo Group, Buddhify Therapy
Keywords
Buddhify, Stress, Anxiety, Relaxation Technique
Medical subject headings
Pain, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo GroupDevice

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

  • Buddhify TherapyDevice

    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 groups in NCT02690194
Study groupRoleWhat they receive
Placebo GroupPlacebo comparator1. 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
Receives: Device: Placebo Group
Experimental (Buddhify) GroupExperimental1. 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
Receives: Device: Buddhify Therapy
Control GroupNo intervention1. Pre-Procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. PROCEDURE 3. Post-procedure -Rate pain level of procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Pre-therapy/pre-procedure

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

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

    Measured: Pre-therapy/pre-procedure

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

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

    Measured: Pre-therapy/pre-procedure

  4. 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.

    Measured: Pre-therapy/pre-procedure

Secondary outcomes (10)

  1. Post-therapy/Pre-procedure Change in Stress Level Measured by Pulse

    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.

    Measured: Post-therapy/pre-procedure

  2. Post-therapy/Pre-procedure Change in Stress Level Measured by Respiration Rate

    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.

    Measured: Post-therapy/pre-procedure

  3. Post-therapy/Pre-procedure Change in Anxiety Level

    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.

    Measured: Post-therapy/pre-procedure

  4. Post-therapy/Pre-procedure Change in Stress Level Measured by Blood Pressure

    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.

    Measured: Post-therapy/Pre-procedure

  5. Perceived Pain Level of the Procedure as Assessed by the Wong-Baker FACES Pain Rating Scale

    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).

    Measured: Immediately post-procedure

  6. Drink in Last Hour

    Indication of if the patient has had a drink in the last hour

    Measured: Pre-therapy/Pre-procedure

  7. Eat in Last Hour

    Indication of if the patient has eaten in the last hour

    Measured: Pre-therapy/Pre-procedure

  8. Exercise in Last Hour

    Indication of if the patient has exercised in the last hour

    Measured: Pre-therapy/Pre-procedure

  9. Injection Experiences

    Indication of prior injection experiences

    Measured: Pre-therapy/Pre-procedure

  10. Number of Injections

    Average number of injections for patients that indicated that they previously have had injections

    Measured: Pre-therapy/Pre-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2016 (estimated)
  2. Study startAug 2015
  3. Primary completion10 Jan 2017
  4. Study completion10 Jan 2017

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02690194
Sponsor's protocol ID
IRB-P00016464
Status last verified
Dec 2018
First submitted
9 Feb 2016
Last updated
21 Dec 2018
Data monitoring committee
No
Individual data sharing
No

Publications

  • Bae H, Bae H, Min BI, Cho S. Efficacy of acupuncture in reducing preoperative anxiety: a meta-analysis. Evid Based Complement Alternat Med. 2014;2014:850367. doi: 10.1155/2014/850367. Epub 2014 Sep 2.

    PubMed 25254059

  • Ko YL, Lin PC. The effect of using a relaxation tape on pulse, respiration, blood pressure and anxiety levels of surgical patients. J Clin Nurs. 2012 Mar;21(5-6):689-97. doi: 10.1111/j.1365-2702.2011.03818.x. Epub 2011 Nov 17.

    PubMed 22092955

  • Ebrecht M, Hextall J, Kirtley LG, Taylor A, Dyson M, Weinman J. Perceived stress and cortisol levels predict speed of wound healing in healthy male adults. Psychoneuroendocrinology. 2004 Jul;29(6):798-809. doi: 10.1016/S0306-4530(03)00144-6.

    PubMed 15110929

  • Worley CA. 'Why won't this wound heal?' Factors affecting wound repair. Dermatol Nurs. 2004 Aug;16(4):360-1. No abstract available.

    PubMed 15471050

  • Lim YC, Yobas P, Chen HC. Efficacy of relaxation intervention on pain, self-efficacy, and stress-related variables in patients following total knee replacement surgery. Pain Manag Nurs. 2014 Dec;15(4):888-96. doi: 10.1016/j.pmn.2014.02.001. Epub 2014 Jun 21.

    PubMed 24957817

  • Kiecolt-Glaser JK, Marucha PT, Malarkey WB, Mercado AM, Glaser R. Slowing of wound healing by psychological stress. Lancet. 1995 Nov 4;346(8984):1194-6. doi: 10.1016/s0140-6736(95)92899-5.

    PubMed 7475659

  • Heilbrunn BR, Wittern RE, Lee JB, Pham PK, Hamilton AH, Nager AL. Reducing anxiety in the pediatric emergency department: a comparative trial. J Emerg Med. 2014 Dec;47(6):623-31. doi: 10.1016/j.jemermed.2014.06.052. Epub 2014 Sep 27.

    PubMed 25271180

  • Sugimoto D, Slick NR, Mendel DL, Stein CJ, Pluhar E, Fraser JL, Meehan WP 3rd, Corrado GD. Meditation Monologue can Reduce Clinical Injection-Related Anxiety: Randomized Controlled Trial. J Evid Based Integr Med. 2021 Jan-Dec;26:2515690X211006031. doi: 10.1177/2515690X211006031.

    PubMed 33904781

Questions about this trial

What is this clinical trial studying?

A study testing Buddhify Therapy in people with Pain and Anxiety, run by Boston Children's Hospital at 1 site in United States.

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 1 inclusion and 0 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 21 Dec 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 States. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 21 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure (time frame: Pre-therapy/pre-procedure). 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?

On the ClinicalTrials.gov record for NCT02690194, which also lists 8 linked publications.

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 21 Dec 2018.

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