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

20. desember 2018 oppdatert av: Gianmichel Corrado, Boston Children's Hospital

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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

54

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Boston Childrens Hospital - Sports Medicine

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

14 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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:

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: 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
The placebo group will wear headphones and listen to nature sounds.
Eksperimentell: 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
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.
Ingen inngripen: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure
Tidsramme: Pre-therapy/pre-procedure
Pre-therapy/pre-procedure stress level measured by blood pressure in mmHg
Pre-therapy/pre-procedure
Pre-therapy/Pre-procedure Stress Level Measured by Pulse
Tidsramme: Pre-therapy/pre-procedure
Pre-therapy/pre-procedure stress level measured by pulse in beats per minute.
Pre-therapy/pre-procedure
Pre-therapy/Pre-procedure Stress Level Measured by Respiratory Rate
Tidsramme: Pre-therapy/pre-procedure
Pre-therapy/pre-procedure stress level measured by respiratory rate in breaths per minute.
Pre-therapy/pre-procedure
Pre-therapy/Pre-procedure Anxiety Level
Tidsramme: 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.
Pre-therapy/pre-procedure

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Post-therapy/Pre-procedure Change in Stress Level Measured by Pulse
Tidsramme: 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.
Post-therapy/pre-procedure
Post-therapy/Pre-procedure Change in Stress Level Measured by Respiration Rate
Tidsramme: 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
Post-therapy/Pre-procedure Change in Anxiety Level
Tidsramme: 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
Post-therapy/Pre-procedure Change in Stress Level Measured by Blood Pressure
Tidsramme: 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.
Post-therapy/Pre-procedure
Perceived Pain Level of the Procedure as Assessed by the Wong-Baker FACES Pain Rating Scale
Tidsramme: 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).
Immediately post-procedure
Drink in Last Hour
Tidsramme: Pre-therapy/Pre-procedure
Indication of if the patient has had a drink in the last hour
Pre-therapy/Pre-procedure
Eat in Last Hour
Tidsramme: Pre-therapy/Pre-procedure
Indication of if the patient has eaten in the last hour
Pre-therapy/Pre-procedure
Exercise in Last Hour
Tidsramme: Pre-therapy/Pre-procedure
Indication of if the patient has exercised in the last hour
Pre-therapy/Pre-procedure
Injection Experiences
Tidsramme: Pre-therapy/Pre-procedure
Indication of prior injection experiences
Pre-therapy/Pre-procedure
Number of Injections
Tidsramme: Pre-therapy/Pre-procedure
Average number of injections for patients that indicated that they previously have had injections
Pre-therapy/Pre-procedure

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Gianmichel Corrado, MD, Boston Children's Hospital

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2015

Primær fullføring (Faktiske)

10. januar 2017

Studiet fullført (Faktiske)

10. januar 2017

Datoer for studieregistrering

Først innsendt

9. februar 2016

Først innsendt som oppfylte QC-kriteriene

19. februar 2016

Først lagt ut (Anslag)

24. februar 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. desember 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. desember 2018

Sist bekreftet

1. desember 2018

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • IRB-P00016464

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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