Laboratory-based Hypnosis Intervention on Pain Responsivity in Adolescents With Sickle Cell Disease
2 listopada 2020 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
25
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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California
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Los Angeles, California, Stany Zjednoczone, 90095
- University of California, Los Angeles
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
12 lat do 21 lat (Dziecko, Dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Aktywny 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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Eksperymentalny: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in peripheral blood flow before and during the intervention
Ramy czasowe: Beginning 15 minutes prior to the intervention (hypnosis or attention control) and continuing during 30 minutes of the intervention
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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).
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Beginning 15 minutes prior to the intervention (hypnosis or attention control) and continuing during 30 minutes of the intervention
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in pain threshold temperature
Ramy czasowe: 12 minutes before the start of the intervention and 15 minutes after the start of the intervention.
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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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
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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
|
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Change in the effect of the intervention on pain threshold temperature at different levels of disease-related stigma
Ramy czasowe: 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.
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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 the effect of the intervention on pain tolerance temperature at different levels of disease-related stigma
Ramy czasowe: 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.
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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 the effect of the intervention on heat pulse pain intensity ratings at different levels of disease-related stigma
Ramy czasowe: 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.
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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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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in the effect of the intervention on Skin Conductance Response (SCR)
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Współpracownicy
Śledczy
- Krzesło do nauki: Lonnie K Zeltzer, MD, UCLA Pediatric Pain and Palliative Care Program
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
16 marca 2018
Zakończenie podstawowe (Rzeczywisty)
30 czerwca 2020
Ukończenie studiów (Rzeczywisty)
1 listopada 2020
Daty rejestracji na studia
Pierwszy przesłany
1 grudnia 2016
Pierwszy przesłany, który spełnia kryteria kontroli jakości
6 grudnia 2016
Pierwszy wysłany (Oszacować)
9 grudnia 2016
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
4 listopada 2020
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
2 listopada 2020
Ostatnia weryfikacja
1 listopada 2020
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- F32sarahmartin2
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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