Hematologic MalignancyNCT06792630
A Study of the Effect of Laughter Therapy on the Mental Health and Quality of Survival of Hematopoietic Stem Cell Transplant Patients
A study testing laughter therapy intervention in people with Hematologic Malignancy and Hematopoietic Stem Cell Transplant, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
主要研究目的： 1)探讨笑疗法在造血干细胞移植患者移植心理健康及生存质量中的效果。 次要研究目的： 1. 了解造血干细胞移植患者移植后3个月、6个月、1年内的心理健康变化和生存质量水平； 2. 探讨笑疗法在造血干细胞移植患者预后等结局指标中的应用效果。 Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hematologic Malignancy, Hematopoietic Stem Cell Transplant
- What is being tested?
- laughter therapy intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2025to 30 Nov 2026
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with a pathologically confirmed diagnosis of hematologic malignancy; Patients undergoing their first hematopoietic stem cell transplant; Age ≥ 16 years; Those who have some reading and writing ability; Those who can cooperate in completing the questionnaires and assessments; Informed consent and voluntary participation in the study.
Who cannot join
- Those with severe mental illness or personality disorders; Those who cannot operate a smartphone independently; Those with severe visual and hearing impairments; Those who are critically ill and cannot receive the intervention.
About this study
主要研究目的：
1)探讨笑疗法在造血干细胞移植患者移植心理健康及生存质量中的效果。 次要研究目的：
- 了解造血干细胞移植患者移植后3个月、6个月、1年内的心理健康变化和生存质量水平；
- 探讨笑疗法在造血干细胞移植患者预后等结局指标中的应用效果。
Read the detailed description
本研究将采用单中心、前瞻性的平行随机对照试验对2024年12月1日至2025年12月1日期间首次接受造血干细胞移植的患者进行招募。对照组实施常规护理措施和出院的常规延续护理措施，干预组从移植+1天开始进行笑治疗，住院期间为移植后+1天至出仓，按照笑的口令"hihihi（拼音拼读），哈哈哈，茄子茄子茄子，七喜七喜七喜，哈哈哈哈哈哈"，30遍口令为1次训练，1天进行1次。出仓及出院后，干预组患者集中线上笑疗法干预，1次/周，重复30遍口令，至移植后1年。分别于移植后3个月、6个月、1年对两组患者在预后、疲劳、焦虑及抑郁、幸福感以及创伤后成长、生存质量及结局指标上进行组间比较，明确笑疗法在造血干细胞移植患者心理健康及生存质量中的效果。
- Being tested
- laughter therapy intervention
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laughter therapy interventionBehavioural
In addition, patients in the intervention group were given laughter therapy intervention from the 1st day of HSCT, with the mnemonic "hihihi (pinyin spelling), hahahaha, eggplant eggplant eggplant, qixi qixi qixi qixi, hahahahahahahahaha," 30 times of the mnemonic as a training session, once a day, from the beginning of the transplantation transfusion +1d to the end of the transplantation transfusion +1d, and then to the end of the transplantation. Patients were discharged from the warehouse, and after discharge, patients were centralized on-line laughter therapy intervention, 1 time/week, repeating 30 times of mnemonics, until 1 year after transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | In addition, patients in the intervention group were given laughter therapy intervention from the 1st day of HSCT, with the mnemonic "hihihi (pinyin spelling), hahahaha, eggplant eggplant eggplant, qixi qixi qixi qixi, hahahahahahahahaha," 30 times of the mnemonic as a training session, once a day, from the beginning of the transplantation transfusion +1d to the end of the transplantation transfusion +1d, and then to the end of the transplantation. Patients were discharged from the warehouse, and after discharge, patients were centralized on-line laughter therapy intervention, 1 time/week, repeating 30 times of mnemonics, until 1 year after transplantation. Receives: Behavioral: laughter therapy intervention |
| Control group | No intervention | atients in the intervention group and the control group were given standard therapeutic measures as well as routine care during hospitalization and after discharge in accordance with the recommendations of the appropriate treatment guidelines. The control group used routine nursing education and continuity of care after discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
time between the start of randomization and death from any cause
Measured: 3 months, 6 months, and 1 year
Progression-free survival
time between the start of randomization and progression of the tumor in any respect or death from any cause
Measured: 3 months, 6 months, and 1 year
Time to treatment failure
time from start of randomization to withdrawal from the trial, withdrawal may be due to patient refusal, disease progression, death, adverse events
Measured: 3 months, 6 months, and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start31 Jan 2025 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792630
- Sponsor's protocol ID
- QTJC2024057
- Status last verified
- Dec 2024
- First submitted
- 27 Dec 2024
- Last updated
- 24 Jan 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 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effect of Laughter Therapy on the Mental Health and Quality of Survival of Hematopoietic Stem Cell Transplant Patients
- ClinicalTrials.gov ID
- NCT06792630
- Acronym / sponsor ID
- QTJC2024057
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 31 Jan 2025 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 24 Jan 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.
主要研究目的：
1)探讨笑疗法在造血干细胞移植患者移植心理健康及生存质量中的效果。 次要研究目的：
- 了解造血干细胞移植患者移植后3个月、6个月、1年内的心理健康变化和生存质量水平；
- 探讨笑疗法在造血干细胞移植患者预后等结局指标中的应用效果。
Detailed description
本研究将采用单中心、前瞻性的平行随机对照试验对2024年12月1日至2025年12月1日期间首次接受造血干细胞移植的患者进行招募。对照组实施常规护理措施和出院的常规延续护理措施，干预组从移植+1天开始进行笑治疗，住院期间为移植后+1天至出仓，按照笑的口令"hihihi（拼音拼读），哈哈哈，茄子茄子茄子，七喜七喜七喜，哈哈哈哈哈哈"，30遍口令为1次训练，1天进行1次。出仓及出院后，干预组患者集中线上笑疗法干预，1次/周，重复30遍口令，至移植后1年。分别于移植后3个月、6个月、1年对两组患者在预后、疲劳、焦虑及抑郁、幸福感以及创伤后成长、生存质量及结局指标上进行组间比较，明确笑疗法在造血干细胞移植患者心理健康及生存质量中的效果。
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: laughter therapy interventionIn addition, patients in the intervention group were given laughter therapy intervention from the 1st day of HSCT, with the mnemonic "hihihi (pinyin spelling), hahahaha, eggplant eggplant eggplant, qixi qixi qixi qixi, hahahahahahahahaha," 30 times of the mnemonic as a training session, once a day, from the beginning of the transplantation transfusion +1d to the end of the transplantation transfusion +1d, and then to the end of the transplantation. Patients were discharged from the warehouse, and after discharge, patients were centralized on-line laughter therapy intervention, 1 time/week, repeating 30 times of mnemonics, until 1 year after transplantation. |
| Control group | No intervention | –atients in the intervention group and the control group were given standard therapeutic measures as well as routine care during hospitalization and after discharge in accordance with the recommendations of the appropriate treatment guidelines. The control group used routine nursing education and continuity of care after discharge. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a pathologically confirmed diagnosis of hematologic malignancy; Patients undergoing their first hematopoietic stem cell transplant; Age ≥ 16 years; Those who have some reading and writing ability; Those who can cooperate in completing the questionnaires and assessments; Informed consent and voluntary participation in the study.
Key exclusion criteria (1 listed)
- Those with severe mental illness or personality disorders; Those who cannot operate a smartphone independently; Those with severe visual and hearing impairments; Those who are critically ill and cannot receive the intervention.
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 therapy interventionIn addition, patients in the intervention group were given laughter therapy intervention from the 1st day of HSCT, with the mnemonic "hihihi (pinyin spelling), hahahaha, eggplant eggplant eggplant, qixi qixi qixi qixi, hahahahahahahahaha," 30 times of the mnemonic as a training session, once a day, from the beginning of the transplantation transfusion +1d to the end of the transplantation transfusion +1d, and then to the end of the transplantation. Patients were discharged from the warehouse, and after discharge, patients were centralized on-line laughter therapy intervention, 1 time/week, repeating 30 times of mnemonics, until 1 year after transplantation. | Behavioural | Intervention group |
Primary outcome
Overall survival
Time frame: 3 months, 6 months, and 1 year
time between the start of randomization and death from any cause
Progression-free survival
Time frame: 3 months, 6 months, and 1 year
time between the start of randomization and progression of the tumor in any respect or death from any cause
Time to treatment failure
Time frame: 3 months, 6 months, and 1 year
time from start of randomization to withdrawal from the trial, withdrawal may be due to patient refusal, disease progression, death, adverse events
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 24 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing laughter therapy intervention in people with Hematologic Malignancy and Hematopoietic Stem Cell Transplant, run by Institute of Hematology & Blood Diseases Hospital, China.
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 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 3 months, 6 months, and 1 year). The study lists 3 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 24 Jan 2025.