Investigation of the Effectiveness of Virtual Reality (VR) Hypnosis in Improving Poor Sleep Among Chinese Childhood Cancer Survivors

Официальное название

Investigation of the Effectiveness of Virtual Reality (VR) Hypnosis in Improving Poor Sleep Among Chinese Childhood Cancer Survivors: A Mixed Methods Randomized Controlled Trial

Обзор

The study aims to examine the effectiveness of virtual reality (VR) hypnosis for improving sleep in among Chinese childhood cancer survivors. Investigators will conduct a three-arm mixed-methods randomized controlled trial (RCT) among 186 Chinese Childhood Cancer Survivors (CCCs). The three groups are VR hypnosis, cognitive behavioral therapy for insomnia (CBT-I), and VR relaxation. The VR hypnosis intervention contains six 30-minute sessions conducted by a clinical psychologist on 6 consecutive Saturdays in Hong Kong Children's Hospital (HKCH) or participants' home depend on participants' preference. Instead of treatment-as-usual and sleep hygiene groups, investigators will use the CBT-I as the active control because it is recommended as a first-line treatment for poor sleep. CBT-I group will have six 30-minute sessions in HKCH or home depend on participants' preference on six consecutive Saturdays. The VR relaxation group will allow us to distinguish the effects of VR from those of VR hypnosis, which has the same length and delivery mode as VR hypnosis, but without a hypnosis component. The study will be conducted at HKCH, which is the only hospital in HK that provides medical follow-ups for children with cancer. Data collection will be done at baseline, as well as immediately and 1, 3, and 6 months after completion of the intervention. Multiple assessment timepoints will capture changes over time.

Вмешательства

• Поведенческое VR hypnosis
  Participants will individually complete VR hypnosis, comprising six 30-minute sessions, conducted by a clinical psychologist on 6 consecutive Saturdays in Hong Kong Children's Hospital or home depend on participants' preference. Participants will be asked to wear head-mounted glasses which can display different scenarios. The participant will select one scenario on the basis of preference. In phase 1 (induction), a narrator will ask the participant to complete various tasks, such as naming anima
• Поведенческое VR relaxation
  Participants will take part in a VR relaxation intervention supervised by a research assistant in Hong Kong Children's Hospital or participants' home depend on participants' preference, which comprises six 30-minute sessions, will be conducted on 6 consecutive Saturdays. The head-mounted display will show five relaxing scenarios (exploring an island, walking through a forest, observing different animals, climbing a mountain, and swimming in the sea), but without a hypnosis component.
• Поведенческое CBT-I
  It will have six 30-minute sessions delivered by a clinical psychologist in Hong Kong Children's Hospital or home depend on participants' preference on six consecutive Saturdays in a standard sequence: (1) psychoeducation which provides information on sleep, its function and characteristics, (2) sleep hygiene, in which guidelines that promote healthy sleep are followed, (3) stimulus control, which breaks the association between bedtime and anxiety by avoiding any activities in bed not related to

Первичные конечные точки

• subjective sleep quality [Срок оценки: Baseline, immediately after completing the intervention, 1 month after completion of the intervention, 3 months after completion of the intervention, 6 months after completion of the intervention]

Вторичные конечные точки (12)

• total sleep time [Срок оценки: Over a course of 7 days before the intervention begins, immediately after completing the intervention, 1 month after completion of the intervention, 3 months after completion of the intervention, 6 months after completion of the intervention]
• sleep-onset latency [Срок оценки: Over a course of 7 days before the intervention begins, immediately after completing the intervention, 1 month after completion of the intervention, 3 months after completion of the intervention, 6 months after completion of the intervention]
• sleep efficiency [Срок оценки: Over a course of 7 days before the intervention begins, immediately after completing the intervention, 1 month after completion of the intervention, 3 months after completion of the intervention, 6 months after completion of the intervention]
• awakening frequency after sleep onset [Срок оценки: Over a course of 7 days before the intervention begins, immediately after completing the intervention, 1 month after completion of the intervention, 3 months after completion of the intervention, 6 months after completion of the intervention]
• sleep fragmentation index [Срок оценки: Over a course of 7 days before the intervention begins, immediately after completing the intervention, 1 month after completion of the intervention, 3 months after completion of the intervention, 6 months after completion of the intervention]
• brain electrophysiological activities [Срок оценки: Two consecutive nights at baseline, during the intervention period (5 minutes before, during, and 5 minutes after hypnosis), one night immediately after completing the intervention, and one night at 6-month follow-up]
• usefulness [Срок оценки: 6 months after completion of the intervention]
• incremental cost-effectiveness ratio (ICER) [Срок оценки: Immediately after completing the intervention, 1 month after completion of the intervention, 3 months after completion of the intervention, 6 months after completion of the intervention]
• depressive symptoms [Срок оценки: Baseline, immediately after completing the intervention, 1 month after completion of the intervention, 3 months after completion of the intervention, 6 months after completion of the intervention]
• cancer-related fatigue [Срок оценки: Baseline, immediately after completing the intervention, 1 month after completion of the intervention, 3 months after completion of the intervention, 6 months after completion of the intervention]
• pain level [Срок оценки: Baseline, immediately after completing the intervention, 1 month after completion of the intervention, 3 months after completion of the intervention, 6 months after completion of the intervention]
• quality of life (QoL) [Срок оценки: Baseline, on completion of the intervention, 1 month after completion of the intervention, 3 months after completion of the intervention, 6 months after completion of the intervention]

Критерии участия

Критерии включения

• completed active cancer treatment for ≥1 month
• able to speak Cantonese and read Chinese
• aged 12-18 years
• poor sleeper as indicated by a PSQI score ≥ 5

Критерии исключения

• Survivors with learning and/or behavioral problems in medical records and those who are using sleep medication and/or previously experienced any adverse events (e.g., headache and motion sickness) when using VR

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Гонконг · 1 центр

• The Hong Kong Polytechnic University — Гонконг

Идентификаторы

NCT: NCT07279168 · Virtual reality (VR) hypnosis

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗