CancerNCT07279168
Investigation of the Effectiveness of Virtual Reality (VR) Hypnosis in Improving Poor Sleep Among Chinese Childhood Cancer Survivors
A study testing VR hypnosis, VR relaxation and CBT-I in people with Cancer, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Cancer
- What is being tested?
- VR hypnosis, VR relaxation and CBT-I
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2026to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Investigation of the Effectiveness of Virtual Reality (VR) Hypnosis in Improving Poor Sleep Among Chinese Childhood Cancer Survivors: A Mixed Methods Randomized Controlled Trial
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
- Being tested
- VR hypnosis, VR relaxation, CBT-I
- Keywords
- virtual reality hypnosis, Chinese childhood cancer survivors, sleep
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR hypnosisBehavioural
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 relaxationBehavioural
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.
CBT-IBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CBT-I | Active comparator | Not described Receives: 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. Receives: Behavioral: VR relaxation |
| VR hypnosis | Experimental | Not described Receives: Behavioral: VR hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
All participants will wear the Actigraph wGT3X-BT to collect data on total sleep time.
Measured: 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
All participants will wear the Actigraph wGT3X-BT to collect data on sleep-onset latency.
Measured: 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
All participants will wear the Actigraph wGT3X-BT to collect data on sleep efficiency.
Measured: 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
All participants will wear the Actigraph wGT3X-BT to collect data on awakening frequency after sleep onset.
Measured: 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
All participants will wear the Actigraph wGT3X-BT to collect data on sleep fragmentation index.
Measured: 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
Participants in the VR hypnosis group will wear the Somté PSG under the supervision of a sleep technician. In the 6 hypnosis sessions, the electrophysiological record by the Somté PSG will occur. It aims to examine the changes in brain activities associated with hypnosis and explore how the changes may relate to alterations in brain electrophysiological activities in sleep. To record brain activities in sleep, participants in the VR hypnosis group will wear the Somté PSG at different time points.
Measured: 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
Participants in the VR hypnosis group will complete a validated questionnaire to assess perceived usefulness (6 items) of VR hypnosis. Higher scores reflect higher perceived usefulness which can reflect the technological challenges and predict the actual use of technology.
Measured: 6 months after completion of the intervention
incremental cost-effectiveness ratio (ICER)
The cost-effectiveness of VR hypnosis is based on the cost divided by subject sleep quality gained and that divided by Quality-Adjusted Life Year (QALY) gained (derived from QoL).
Measured: 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
The Center for Epidemiological Studies Depression Scale for Children (CES-DC) contains 20 items will be used to assess depressive symptoms. Total scores range from 0 to 60. Higher scores indicate more depressive symptoms. The psychometric properties of the CES-DC have been established in Chinese children with cancer.
Measured: 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
The 12-item Fatigue Scale-Adolescent (FS-A) will be used to measure participants' cancer-related fatigue levels. Higher scores represent higher levels of fatigue. The FS-A is a reliable and valid measure for Chinese CCSs.
Measured: 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
A visual analogue scale will be used to assess participants' pain levels. Participants will indicate their pain scores on a 100-mm horizontal line, with one end indicating no pain and another indicating the worst possible pain. This is a reliable and valid method for assessing pain in CCSs.
Measured: 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)
QoL will be assessed EuroQol five dimensions-youth version-3 level (EQ-5D-Y-3L). It contains five items evaluated on 3 levels. The score will be converted into a single utility score using a published algorithm. This scale was validated in Hong Kong Chinese adolescents, with the normative dataset being built.
Measured: 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
ease of use
Participants in the VR hypnosis group will complete a validated questionnaire to assess perceived ease of use (6 items) of VR hypnosis. Higher scores reflect higher perceived ease of use which can reflect the technological challenges and predict the actual use of technology.
Measured: 6 months after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Research Grants Council, Hong Kong, Hong Kong Children's Hospital
- Responsible party
- Principal investigator, Dr Eva Ho, The Hong Kong Polytechnic University
- Investigators
- Ka Yan Ho, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279168
- Sponsor's protocol ID
- Virtual reality (VR) hypnosis
- Status last verified
- Oct 2025
- First submitted
- 19 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Virtual Reality (VR) Hypnosis in Improving Poor Sleep Among Chinese Childhood Cancer Survivors: A Mixed Methods Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07279168
- Acronym / sponsor ID
- Virtual reality (VR) hypnosis
- Conditions
- Cancer
- Keywords
- virtual reality hypnosis, Chinese childhood cancer survivors, sleep
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Research Grants Council, Hong Kong, Hong Kong Children's Hospital
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBT-I | Active comparator | Behavioral: CBT-I |
| VR relaxation | Other | Behavioral: VR relaxationThe 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. |
| VR hypnosis | Experimental | Behavioral: VR hypnosis |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR hypnosisParticipants 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. | Behavioural | VR hypnosis |
| VR relaxationParticipants 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. | Behavioural | VR relaxation |
| CBT-IIt 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. | Behavioural | CBT-I |
Primary outcome
subjective sleep quality
Time frame: 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
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.
13 secondary outcomes
total sleep time
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months after completion of the intervention
incremental cost-effectiveness ratio (ICER)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
ease of use
Time frame: 6 months after completion of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ka Yan Ho principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR hypnosis, VR relaxation and CBT-I in people with Cancer, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ka Yan Ho (+8527666417, kyeva.ho@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subjective sleep quality (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.