Patiens in Early Stage of ChemotherapyNCT07798661
Laughter Yoga- Integrated Virtual Reality Nature Exploration in Early Stage of Chemotherapy
A study testing laughter yoga-integrated virtual reality in people with Patiens in Early Stage of Chemotherapy, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
After obtaining informed consent, pre-test applications will be performed on participants in the experimental and control groups following randomization, and information regarding treatment plans will be recorded. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patiens in Early Stage of Chemotherapy
- What is being tested?
- laughter yoga-integrated virtual reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2026to 30 Mar 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age, being in the early stage of chemotherapy, no surgical treatment plan, voluntary participation.
Who cannot join
- psychiatric disorder, treatments other than chemotherapy, not in the early stage of chemotherapy vision and hearing problems, planned surgical procedure, skin/eye infections that would prevent the use of virtual reality, previous laughter yoga experience.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Atatürk University Faculty of Nursing
Erzurum, YAKUTİYE, 25240
About this study
Official title: The Effect of Laughter Yoga- Integrated Virtual Reality Nature Exploration on Anxiety and Insomnia of Patients in Early Stage of Chemotherapy
After obtaining informed consent, pre-test applications will be performed on participants in the experimental and control groups following randomization, and information regarding treatment plans will be recorded. Patients in the experimental group will receive laughter yoga practice integrated with virtual reality videos during chemotherapy infusion. The practice is planned to be once a week for four weeks. High-resolution, adjustable virtual reality glasses with head and hand tracking features will be used for the virtual reality application. The videos will consist of relaxing content such as nature walks, beach and sea views, and will be prepared in three-dimensional, 360-degree viewing angles integrated with laughter yoga exercises. Personalized video content will be created according to the participants' preferences, and the viewing time will be limited to 10 minutes for each application. After the completion of the fourth course, data collection tools will be re-administered for post-testing purposes.
- Conditions
- Patiens in Early Stage of Chemotherapy
- Being tested
- laughter yoga-integrated virtual reality
- Keywords
- laughter yoga, anxiety, cancer, chemotherapy, virtual reality, insomnia
- Medical subject headings
- Anxiety Disorders, Neoplasms, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laughter yoga-integrated virtual realityBehavioural
A digital-based behavioral approach for symptom control
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Not described |
| interviention | Experimental | laughter yoga-integrated Vİrtual Reality Receives: Behavioral: laughter yoga-integrated virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index
This self-report scale, used to assess sleep quality and sleep-related problems, consists of seven components. The scale was first developed by Buysse et al. in 1989, and studies have shown that it has sufficient internal consistency (Cronbach's alpha=0.80), test-retest reliability, and construct validity. The Turkish validity and reliability study of the scale was carried out by Ağargün et al., and it was shown that it can be used in the Turkish population.
Measured: 4 week
State-Trait Anxiety Inventory (STAI)
Developed by Spielberger et al. and adapted into Turkish by Öner and Le Compte, this inventory assesses anxiety levels. It includes two subscales, each consisting of 20 items, measuring the individual's immediate anxiety level and general anxiety tendency separately. The scale is evaluated on a four-point Likert scale, with scores ranging from 20 to 80, indicating a higher level of anxiety.
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patiens in Early Stage of ChemotherapyStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Ciraci Yasar, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798661
- Sponsor's protocol ID
- ATATURKU-NRS-16884
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughter Yoga- Integrated Virtual Reality Nature Exploration on Anxiety and Insomnia of Patients in Early Stage of Chemotherapy
- ClinicalTrials.gov ID
- NCT07798661
- Acronym / sponsor ID
- ATATURKU-NRS-16884
- Conditions
- Patiens in Early Stage of Chemotherapy
- Keywords
- laughter yoga, anxiety, cancer, chemotherapy, virtual reality, insomnia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 1 Sep 2026 (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.
After obtaining informed consent, pre-test applications will be performed on participants in the experimental and control groups following randomization, and information regarding treatment plans will be recorded. Patients in the experimental group will receive laughter yoga practice integrated with virtual reality videos during chemotherapy infusion. The practice is planned to be once a week for four weeks. High-resolution, adjustable virtual reality glasses with head and hand tracking features will be used for the virtual reality application. The videos will consist of relaxing content such as nature walks, beach and sea views, and will be prepared in three-dimensional, 360-degree viewing angles integrated with laughter yoga exercises. Personalized video content will be created according to the participants' preferences, and the viewing time will be limited to 10 minutes for each application. After the completion of the fourth course, data collection tools will be re-administered for post-testing purposes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | – |
| interviention | Experimental | Behavioral: laughter yoga-integrated virtual realitylaughter yoga-integrated Vİrtual Reality |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ≥18 years of age, being in the early stage of chemotherapy, no surgical treatment plan, voluntary participation.
Key exclusion criteria (1 listed)
- psychiatric disorder, treatments other than chemotherapy, not in the early stage of chemotherapy vision and hearing problems, planned surgical procedure, skin/eye infections that would prevent the use of virtual reality, previous laughter yoga experience.
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 |
|---|---|---|
| laughter yoga-integrated virtual realityA digital-based behavioral approach for symptom control | Behavioural | interviention |
Primary outcome
Pittsburgh Sleep Quality Index
Time frame: 4 week
This self-report scale, used to assess sleep quality and sleep-related problems, consists of seven components. The scale was first developed by Buysse et al. in 1989, and studies have shown that it has sufficient internal consistency (Cronbach's alpha=0.80), test-retest reliability, and construct validity. The Turkish validity and reliability study of the scale was carried out by Ağargün et al., and it was shown that it can be used in the Turkish population.
State-Trait Anxiety Inventory (STAI)
Time frame: 4 week
Developed by Spielberger et al. and adapted into Turkish by Öner and Le Compte, this inventory assesses anxiety levels. It includes two subscales, each consisting of 20 items, measuring the individual's immediate anxiety level and general anxiety tendency separately. The scale is evaluated on a four-point Likert scale, with scores ranging from 20 to 80, indicating a higher level of anxiety.
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 1 Sep 2026.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laughter yoga-integrated virtual reality in people with Patiens in Early Stage of Chemotherapy, run by Ataturk University at 1 site in Turkey (Türkiye).
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 1 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 1 Sep 2026. 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 Turkey (Türkiye). 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 yasemin Ciraci, Assist. Prof. (00904422311448, yaseminciraci90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (time frame: 4 week). The study lists 2 primary outcomes in all. 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 1 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.