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

NCT07279168 | Not Yet Recruiting

• 1 other identifier: Virtual reality (VR) hypnosis
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Keywords

virtual reality hypnosis; Chinese childhood cancer survivors; sleep

Outcome Measures

Primary Outcomes (1)

• subjective sleep quality

  The 19-item Pittsburgh Sleep Quality Index (PSQI) will be used to assess participants' subjective sleep quality in the past month. Total scores range from 0 to 57. Poor sleepers have scores ≥ 5. The PSQI is reliable and valid to assess subjective sleep quality.

  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

Secondary Outcomes (13)

• total sleep time

  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

  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

  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

  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

  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

Study Arms (3)

CBT-I

ACTIVE COMPARATOR

Behavioral: CBT-I

VR relaxation

OTHER

The same length and delivery mode as VR hypnosis, but without a hypnosis component. The VR relaxation group will allow us to distinguish the effects of VR from those of VR hypnosis.

Behavioral: VR relaxation

VR hypnosis

EXPERIMENTAL

Behavioral: VR hypnosis

Interventions

VR hypnosis BEHAVIORAL

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 animals that participants see. In phase 2 (deepening), the glasses will continue to show the relaxing scenery, with the narrator guiding the participant to pay attention to their breathing and muscle movements. In phase 3 (suggestion), participants will be guided to change negative thoughts and behaviors arising in response to poor sleep. In phase 4 (reawakening), the participants will be guided to return to the peaceful scene with a renewed sense of focus, such that participants will sleep well.

VR hypnosis

VR relaxation BEHAVIORAL

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.

VR relaxation

CBT-I BEHAVIORAL

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 sleep; (4) sleep restriction, which limits the amount of time in bed to increase the sleep drive, and (5) cognitive restructuring, which replaces negative thoughts of sleep with constructive thoughts; and (6) relaxation techniques that can quiet the mind and the body in preparation for sleep. A sleep diary will be provided along with handouts and worksheets for skill acquisition and practice.

CBT-I

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hong Kong Children's Hospital: collaborator
• The Hong Kong Polytechnic University: lead
• Research Grants Council, Hong Kong: collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Ka Yan Ho

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ka Yan Ho

CONTACT

+8527666417; kyeva.ho@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 12, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: December 12, 2025

Record last verified: 2025-10

Locations

HK (1)