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

NCT ID: NCT07279168

Last Updated: 2025-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2028-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CBT-I

Group Type ACTIVE_COMPARATOR

CBT-I

Intervention Type 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.

VR relaxation

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.

Group Type OTHER

VR relaxation

Intervention Type 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 hypnosis

Group Type EXPERIMENTAL

VR hypnosis

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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 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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Research Grants Council, Hong Kong

OTHER

Sponsor Role collaborator

Hong Kong Children's Hospital

OTHER

Sponsor Role collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr Eva Ho

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ka Yan Ho

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ka Yan Ho

Role: CONTACT

+8527666417

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Virtual reality (VR) hypnosis

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Virtual Reality for Advanced Cancer Pain
NCT06534580 ACTIVE_NOT_RECRUITING