Laboratory-based Hypnosis Intervention on Pain Responsivity in Adolescents With Sickle Cell Disease
2. november 2020 opdateret af: Sarah R. Martin, University of California, Los Angeles
The purpose of this study is to test the effects of a laboratory-based hypnosis session compared to an attention control condition on peripheral blood flow, autonomic stress responses, and acute pain responses in adolescents (ages 12-21) with sickle cell disease, and examine how perceived disease-related stigma may affect these responses.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
25
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
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Los Angeles, California, Forenede Stater, 90095
- University of California, Los Angeles
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
12 år til 21 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- A diagnosis of sickle cell disease
- Age 12-21 years old
- Fluent in English (the intervention will be delivered in English)
- Participant is cognitively able to provide informed signed consent or assent
- Participant is cognitively able to follow instructions
Exclusion Criteria:
- Under 12 years of age or over 21 years of age
- Not fluent in English
- Pain medication prescription has changed or if they have been hospitalized for a vaso-occlusive episode within 30 days of study participation.
- Diagnosis of a condition (e.g., neurological disorder affecting peripheral sensation, skin abnormality over the stimulus site, obstructive sleep apnea, diabetes, ischemic heart disease) or cognitive impairment that may affect data integrity or the ability to complete study procedures.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Attention Control
Participants will listen to a 30-minute historical story.
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A 30-minute historical story read by a research clinician.
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Eksperimentel: Hypnosis
Participants will receive a 30-minute hypnosis session
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A 30-minute Hypnosis session with a trained clinician focused on relaxation and hypnotic suggestions for pain relief and reduced stress responses.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in peripheral blood flow before and during the intervention
Tidsramme: Beginning 15 minutes prior to the intervention (hypnosis or attention control) and continuing during 30 minutes of the intervention
|
Peripheral blood flow will be measured using continuous readings of oxygen saturation, pulse rate, and pulse waveform from the thumb and change in blood flow will be assessed by comparing levels of blood flow during the pre-intervention period (15 minutes prior to intervention to a minute before the start of intervention) from blood flow during the intervention period (from the start of the intervention until 30 minutes after the start of the intervention).
|
Beginning 15 minutes prior to the intervention (hypnosis or attention control) and continuing during 30 minutes of the intervention
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in pain threshold temperature
Tidsramme: 12 minutes before the start of the intervention and 15 minutes after the start of the intervention.
|
Pain threshold temperature will be determined by when participants report they first feel pain and change in pain threshold temperature will be assessed by comparing pain threshold temperature during the pre-intervention period (12 minutes before the start of the intervention) from pain threshold temperature during the intervention period (15 minutes after the start of the intervention).
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12 minutes before the start of the intervention and 15 minutes after the start of the intervention.
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Change in pain tolerance temperature
Tidsramme: 9 minutes before the start of the intervention and 18 minutes after the start of the intervention.
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Pain tolerance temperature will be determined by when participants report they can no longer tolerate the pain and change in pain tolerance temperature will be assessed by comparing pain tolerance temperature during the pre-intervention period (9 minutes before the start of the intervention) from pain tolerance temperature during the intervention period (18 minutes after the start of the intervention).
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9 minutes before the start of the intervention and 18 minutes after the start of the intervention.
|
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Change in heat pulse pain intensity ratings
Tidsramme: 5 minutes before the start of the intervention and 21 minutes after the start of the intervention.
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Heat pulse pain intensity ratings will be determined by participants' self-report of heat pulse pain intensity (rated on a 0-10 scale, with 0 being no pain and 10 being worst pain), and change in heat pulse pain intensity will be assessed by comparing pain tolerance temperature during the pre-intervention period (5 minutes before the start of the intervention) from heat pulse pain intensity during the intervention period (21 minutes after the start of the intervention).
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5 minutes before the start of the intervention and 21 minutes after the start of the intervention.
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Change in the effect of the intervention on peripheral blood flow at different levels of disease-related stigma
Tidsramme: 15 minutes prior to the start of the intervention to a minute before the start of the intervention and from the start of the intervention to 30 minutes after the start of the intervention
|
Stigma will be assessed via a questionnaire completed prior to the start of the laboratory session and will be compared to the change in effect, which is assessed by comparing levels of blood flow during the pre-intervention period (15 minutes prior to intervention to a minute before the start of intervention) from blood flow during the intervention period (from the start of the intervention until 30 minutes after the start of the intervention).
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15 minutes prior to the start of the intervention to a minute before the start of the intervention and from the start of the intervention to 30 minutes after the start of the intervention
|
|
Change in the effect of the intervention on pain threshold temperature at different levels of disease-related stigma
Tidsramme: 12 minutes before the start of the intervention and 15 minutes after the start of the intervention
|
Stigma will be assessed via a questionnaire completed prior to the start of the laboratory session and will be compared to the change in effect, which is assessed by comparing pain threshold collected 12 minutes before the start of the intervention and 15 minutes after the start of the intervention.
|
12 minutes before the start of the intervention and 15 minutes after the start of the intervention
|
|
Change in the effect of the intervention on pain tolerance temperature at different levels of disease-related stigma
Tidsramme: 9 minutes before the start of the intervention and 18 minutes after the start of the intervention.
|
Stigma will be assessed via a questionnaire completed prior to the start of the laboratory session and will be compared to the change in effect, which is assessed by comparing pain tolerance collected 9 minutes before the start of the intervention and 18 minutes after the start of the intervention.
|
9 minutes before the start of the intervention and 18 minutes after the start of the intervention.
|
|
Change in the effect of the intervention on heat pulse pain intensity ratings at different levels of disease-related stigma
Tidsramme: 5 minutes before the start of the intervention and 21 minutes after the start of the intervention.
|
Stigma will be assessed via a questionnaire completed prior to the start of the laboratory session and will be compared to the change in effect, which is assessed by comparing pain intensity collected 5 minutes before the start of the intervention and 21 minutes after the start of the intervention.
|
5 minutes before the start of the intervention and 21 minutes after the start of the intervention.
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in the effect of the intervention on Skin Conductance Response (SCR)
Tidsramme: 12-5 minutes prior to the start of the intervention and 15-21 minutes after the start of the intervention
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Skin Conductance Response (SCR) will be measured using continuous readings of electrical properties of the skin on the index finger and change in SCR will be assessed by comparing levels of SCR during the pre-intervention period (12-5 minutes prior to intervention to the start of intervention) from SCR during the intervention period (15-21 minutes after the start of the intervention).
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12-5 minutes prior to the start of the intervention and 15-21 minutes after the start of the intervention
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Change in the effect of the intervention on Heart Rate Variability
Tidsramme: 12-5 minutes prior to the start of the intervention and 15-21 minutes after the start of the intervention
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Heart Rate Variability (HRV) will be measured using continuous readings of heartbeat intervals and change in HRV will be assessed by comparing HRV during the pre-intervention period (12-5 minutes prior to intervention to the start of intervention) from HRV during the intervention period (15-21 minutes after the start of the intervention).
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12-5 minutes prior to the start of the intervention and 15-21 minutes after the start of the intervention
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Studiestol: Lonnie K Zeltzer, MD, UCLA Pediatric Pain and Palliative Care Program
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
16. marts 2018
Primær færdiggørelse (Faktiske)
30. juni 2020
Studieafslutning (Faktiske)
1. november 2020
Datoer for studieregistrering
Først indsendt
1. december 2016
Først indsendt, der opfyldte QC-kriterier
6. december 2016
Først opslået (Skøn)
9. december 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. november 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. november 2020
Sidst verificeret
1. november 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- F32sarahmartin2
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