Pediatric Cancer, Animal-Assisted ActivitiesHIPPONCT03471221

Helping Improve Pediatric Patient Outcomes

A study testing Therapy Dog Visit in people with Pediatric Cancer, Animal-Assisted Activities, run by Kaiser Permanente at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study involves two distinct activities: The first is a randomized controlled trial (RCT) to assess the efficacy and safety of therapy dog visits for children with cancer. This activity has the following specific objectives: 1. Read more about this study

Who is it for?: Ages 5 to 17 years
Conditions the study is for: Pediatric Cancer, Animal-Assisted Activities
What is being tested?: Therapy Dog Visit
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 2 sitesUnited States
Study dates: 19 Mar 2018to 30 Apr 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 5 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

English-speaking patients aged 5-17 years who have been admitted to the Seattle Children's Hospital Cancer Care Unit and who are on the oncology service irrespective of specific oncologic diagnosis, sex, race, and ethnicity.

Who cannot join

Are allergic to dogs or have a sensitivity to dogs; Are afraid of dogs; Are on the bone marrow transplant service; Have isolation precautions in place per Infection Prevention policies (e.g. viral respiratory precautions, contact precautions, etc.); Skin on hands not intact (e.g. moderate to severe eczema involving the hands or other generalized skin breakdown); Have no English-speaking parent/legal guardian; Have no parent/legal guardian able to provide written consent; For observational study, unwilling or unable to pet the dog with both hands.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98126

Other trials in United States

About this study

Official title: Psychological Benefits and Potential Pathogen Transmission in Hospitalized Pediatric Oncology Patients Receiving Therapy Dog Visits: a Randomized Controlled Trial

This study involves two distinct activities:

The first is a randomized controlled trial (RCT) to assess the efficacy and safety of therapy dog visits for children with cancer. This activity has the following specific objectives:

To assess the effect of therapy dog visits on psychosocial outcomes and satisfaction with care among pediatric oncology inpatients.
To determine whether therapy dog visits increase microbial levels on children's hands.

The Investigators hypothesize that therapy dog visits will reduce patient distress, lower treatment-related anxiety, increase happiness, and improve satisfaction with hospital care. The Investigators further hypothesize that therapy dog visits (including standard hand sanitization) will not increase microbial levels on children's hands.

Once the main study aims for the first study activity have been completed, the research study team will begin recruitment for the second activity. The second activity is an observational study to describe microbial levels before a dog visit, after a dog visit but before hand cleaning, and after hand cleaning. This phase will provide additional information for Aim 2 that cannot be obtained during the RCT given the nature of the RCT design. The Investigators will proceed with the observational study only if all main study activities can be completed within the study timeline.

Read the detailed description

This study tests whether therapy dog visits reduce distress, lower treatment-related anxiety, increase happiness, and improve satisfaction with hospital care, and whether these visits transmit pathogens.

The first activity is a randomized controlled trial (RCT) in which patients will be randomized to either the intervention (therapy dog visits) or control (usual care). All patients will complete a baseline survey and hand sampling (i.e., removal of materials of hands via use of liquid inside a glove) and answer questions from study staff (e.g., about pets at home, which hand is dominant) before randomization. Parents will also complete a baseline survey. Patients in the intervention group will receive therapy dog visits. At the first therapy dog visit after enrollment, the research study team will collect visit-level psychosocial measures and perform hand sampling. Similar procedures will be performed on usual care patients. Patients in the intervention group will receive subsequent dog visits ~1x/week for up to 4 weeks if there sufficient dog team capacity. At hospital discharge, ~3 days post-discharge and 9 weeks post-discharge, the research study team will administer surveys to patients and their parents in both groups.

Informed consent/assent will be performed for patients who agree to participate in the study and preliminarily meet eligibility criteria. The parent/legal guardians of participants who are enrolled in will be approached for their informed consent to complete surveys. After informed consent/assent has been obtained, baseline surveys will be administered and hand samples will be collected. The study staff will then assess the patient's ability to tolerate and willingness to perform future psychological assessments and hand samplings. Patients willing to proceed with the study will be randomized to either the intervention arm (visits from a therapy dog) or the control arm (no visits from a therapy dog). Participants will be randomized (1:1) to each group and stratified by age (≥13 vs <13 years). Participants will maintain their randomization assignment during any subsequent hospitalizations that occur during their participation in the study.

The second activity is an observational study of patients receiving therapy dog visits that will provide additional information on microbial levels. The observational study which involves a one-time therapy dog visit. Children will be instructed to touch the dog with both hands. Both hands will be sampled before the visit. A randomly selected hand will be sampled immediately after the visit (before hand sanitization). The other hand will be sampled after sanitization.

Conditions: Pediatric Cancer, Animal-Assisted Activities
Being tested: Therapy Dog Visit
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Therapy Dog VisitBehavioural
Also called Animal-Assisted Activities
Animal Assisted Activities (AAA) provide opportunities for motivational, educational, recreational, and/or therapeutic benefits to enhance quality of life. AAA are delivered in a variety of environments by specially trained professionals, paraprofessionals, and/or volunteers, in association with animals that meet specific criteria.
Key features of AAA are as follows:
1. Specific treatment goals are not planned for each visit.
2. Volunteers and treatment providers are not required to take detailed notes.
3. Visit content and activities are spontaneous.
4. Visit length can be as long or as short as needed.

Study groups in NCT03471221
Study group	Role	What they receive
Therapy Dog Visits	Experimental	Participants randomized to Therapy Dog Visits will receive a visit from a therapy dog and handler team up to one time per week for up to four weeks, depending on length of hospitalization and therapy dog team capacity. Therapy dog visits will last up to about 20 minutes and activities may include: petting the dog, watching the dog perform a trick, and talking with the dog handler. All activities will follow the current procedures and regulations in place at Seattle Children's Hospital. Receives: Behavioral: Therapy Dog Visit
Control Group	No intervention	Participants randomized to the Control Group will receive usual medical care.

What is being measured

The primary outcome is the main question the study is designed to answer.

Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) Total Distress Score
The Pediatric Quality of Life Present Functioning Visual Analog Scale total score is a measure of present or in-the-moment distress. It is computed as the average of 6 scales (afraid/scared, sad/blue, angry, worry, tired, pain/hurt). Each scale ranges from 0-100, with lower scores indicating lower distress. For the overall score, lower values indicate lower total distress.
Measured: Immediately after first visit (Intention to Treat)
Microbial Load (Colony Forming Units; Cfu) on Child Hands
Microbial load on child hands
Measured: Immediately after first visit (Intention to Treat and Per Protocol)

Secondary outcomes (11)

Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) Total Distress Score
The PedsQL VAS total score is a measure of present or in-the-moment distress. It is computed as the average of 6 scales (afraid/scared, sad/blue, angry, worry, tired, pain/hurt). Each scale ranges from 0-100, with lower scores indicating lower distress. For the overall score, lower values indicate lower total distress.
Measured: Immediately after first visit (Per Protocol)
Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) Individual Scales (Afraid/Scared, Sad/Blue, Angry, Worry, Tired, Pain/Hurt)
Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS). Each of 6 individual scales (afraid/scared, sad/blue, angry, worry, tired, pain/hurt) ranges from 0-100, with lower scores indicating a better outcome.
Measured: Immediately after first visit (Intention to Treat)
Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) Emotional Distress Summary Score.
The PedsQL VAS emotional distress summary score is a measure of present or in-the-moment emotional distress. It is computed as the average of 4 scales (afraid/scared, sad/blue, angry, worry). Each scale ranges from 0-100, with lower scores indicating lower distress. For the overall score, lower values indicate lower emotional distress.
Measured: Immediately after first visit (Intention to Treat)
Number of Participants With the Presence of Clinically Important Organisms
The presence of each of the following nine organisms:
Staphylococcus aureus (further evaluated for methicillin-resistance); Vancomycin-resistant enterococci; Malassezia; Aspergillus; Pasteurella; Enterobacteriaceae (further assessed for multidrug resistance); Acinetobacter (further assessed for multidrug resistance); Pseudomonas aeruginosa (further assessed for multidrug resistance); Clostridium difficile
Measured: Immediately after first visit (Intention to Treat and Per Protocol)
Pediatric Quality of Life Inventory (PedsQL) Cancer Module: Treatment Anxiety Dimension
Treatment anxiety is one dimension measured within the PedsQL Cancer Module. It consists of 3 questions on a Likert scale. Items are reversed scored and linearly transformed on a 0-100 scale and then averaged. Higher scores indicate lower treatment anxiety.
Measured: Hospital discharge (hospital discharge date varies by patient), 3 days post-hospital discharge, and 9-weeks post-hospital discharge, (Intention to Treat)
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Each feeling (afraid/scared, sad/blue, angry, worried) is measured as either, not present, a little bit present, present, or strongly present.
Measured: Hospital discharge (hospital discharge date varies by patient), 3 days post-hospital discharge, and 9-weeks post-hospital discharge), (Intention to Treat)
The Positive and Negative Affect Schedule (PANAS): Parent Measure of Child's Positive Affect
The parent report of the child's positive affect consists of 5 positive feelings/emotions each scored on a 5-point Likert scale. Low scores represent worse outcomes. The total score (range: 5-25) is obtained by summing the items.
Measured: Primary: Hospital discharge (hospital discharge date varies by patient); secondary: 3 days post-hospital discharge and 9-weeks post-hospital discharge (Intention to Treat)
The Positive and Negative Affect Schedule (PANAS): Parent Measure of Child's Negative Affect
The parent report of the child's negative affect consists of 5 negative feelings/emotions each scored on a 5-point Likert scale. Low scores represent better outcomes. The total score (range: 5-25) is obtained by summing the items.
Measured: Primary: Hospital discharge (hospital discharge date varies by patient); secondary: 3 days post-hospital discharge and 9-weeks post-hospital discharge (Intention to Treat)
Six-item Short-form of the State Scale of the Spielberger State-Trait Anxiety Inventory (STAI)
The short form of the Spielberger State-Trait Anxiety scale will be used to measure parent anxiety. It consists of six items, each on a 4-point Likert scale. The total score is obtained by reverse scoring the three positive items, summing the six scores together, and then multiplying by 20/6. Total scores range from 20 to 80 with higher numbers representing worse outcomes. Nineteen parents participated (9 from the intervention group and 10 from the control group).
Measured: Immediately after first visit, (Intention to Treat)
Parent Rating of Hospital
Parents rate the hospital on a 11-point Likert scale. Scores range from 0 to 10. Lower scores represent worse hospital ratings.
Measured: Primary: Hospital discharge (hospital discharge date varies by patient); secondary: 3 days post-hospital discharge and 9-weeks post-hospital discharge (Intention to Treat)
Microbial Load (Colony Forming Units; Cfu) on Hands That Touched the Dog Versus Hands of Medically Eligible Controls
Microbial load on hands that touched the dog versus hands of medically eligible controls
Measured: Immediately after first visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Mar 201830 Apr 2020

First posted20 Mar 2018
Study start19 Mar 2018
Primary completion29 Feb 2020
Study completion30 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pediatric Cancer, Animal-Assisted ActivitiesStudies 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: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03471221
Sponsor's protocol ID: 1R21HD091877
Acronym: HIPPO
Status last verified: Jun 2026
First submitted: 16 Feb 2018
Last updated: 15 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Chubak J, Adler A, Bobb JF, Hawkes RJ, Ziebell RA, Pocobelli G, Ludman EJ, Zerr DM. A Randomized Controlled Trial of Animal-assisted Activities for Pediatric Oncology Patients: Psychosocial and Microbial Outcomes. J Pediatr Health Care. 2024 May-Jun;38(3):354-364. doi: 10.1016/j.pedhc.2023.09.010. Epub 2023 Nov 4.
PubMed 37930283

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Psychological Benefits and Potential Pathogen Transmission in Hospitalized Pediatric Oncology Patients Receiving Therapy Dog Visits: a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03471221
Acronym / sponsor ID: HIPPO / 1R21HD091877
Conditions: Pediatric Cancer, Animal-Assisted Activities
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Kaiser PermanenteUniversity, hospital or other
Collaborators: Seattle Children's Hospital
Study start: 19 Mar 2018 (actual)
Primary completion: 29 Feb 2020 (actual)
Study completion: 30 Apr 2020 (actual)
First posted: 20 Mar 2018 (actual)
Results: Posted 15 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study involves two distinct activities:

The first is a randomized controlled trial (RCT) to assess the efficacy and safety of therapy dog visits for children with cancer. This activity has the following specific objectives:

To assess the effect of therapy dog visits on psychosocial outcomes and satisfaction with care among pediatric oncology inpatients.
To determine whether therapy dog visits increase microbial levels on children's hands.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Therapy Dog Visits	Experimental	Behavioral: Therapy Dog VisitParticipants randomized to Therapy Dog Visits will receive a visit from a therapy dog and handler team up to one time per week for up to four weeks, depending on length of hospitalization and therapy dog team capacity. Therapy dog visits will last up to about 20 minutes and activities may include: petting the dog, watching the dog perform a trick, and talking with the dog handler. All activities will follow the current procedures and regulations in place at Seattle Children's Hospital.
Control Group	No intervention	–Participants randomized to the Control Group will receive usual medical care.

Who may qualify

Ages: 5 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

English-speaking patients aged 5-17 years who have been admitted to the Seattle Children's Hospital Cancer Care Unit and who are on the oncology service irrespective of specific oncologic diagnosis, sex, race, and ethnicity.

Key exclusion criteria (1 listed)

Are allergic to dogs or have a sensitivity to dogs; Are afraid of dogs; Are on the bone marrow transplant service; Have isolation precautions in place per Infection Prevention policies (e.g. viral respiratory precautions, contact precautions, etc.); Skin on hands not intact (e.g. moderate to severe eczema involving the hands or other generalized skin breakdown); Have no English-speaking parent/legal guardian; Have no parent/legal guardian able to provide written consent; For observational study, unwilling or unable to pet the dog with both hands.

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
Therapy Dog VisitAlso: Animal-Assisted ActivitiesAnimal Assisted Activities (AAA) provide opportunities for motivational, educational, recreational, and/or therapeutic benefits to enhance quality of life. AAA are delivered in a variety of environments by specially trained professionals, paraprofessionals, and/or volunteers, in association with animals that meet specific criteria. Key features of AAA are as follows: 1. Specific treatment goals are not planned for each visit. 2. Volunteers and treatment providers are not required to take detailed notes. 3. Visit content and activities are spontaneous. 4. Visit length can be as long or as short as needed.	Behavioural	Therapy Dog Visits

Primary outcome

Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) Total Distress Score
Time frame: Immediately after first visit (Intention to Treat)
The Pediatric Quality of Life Present Functioning Visual Analog Scale total score is a measure of present or in-the-moment distress. It is computed as the average of 6 scales (afraid/scared, sad/blue, angry, worry, tired, pain/hurt). Each scale ranges from 0-100, with lower scores indicating lower distress. For the overall score, lower values indicate lower total distress.
Microbial Load (Colony Forming Units; Cfu) on Child Hands
Time frame: Immediately after first visit (Intention to Treat and Per Protocol)
Microbial load on child hands

11 secondary outcomes

Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) Total Distress Score
Time frame: Immediately after first visit (Per Protocol)
Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) Individual Scales (Afraid/Scared, Sad/Blue, Angry, Worry, Tired, Pain/Hurt)
Time frame: Immediately after first visit (Intention to Treat)
Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) Emotional Distress Summary Score.
Time frame: Immediately after first visit (Intention to Treat)
Number of Participants With the Presence of Clinically Important Organisms
Time frame: Immediately after first visit (Intention to Treat and Per Protocol)
Pediatric Quality of Life Inventory (PedsQL) Cancer Module: Treatment Anxiety Dimension
Time frame: Hospital discharge (hospital discharge date varies by patient), 3 days post-hospital discharge, and 9-weeks post-hospital discharge, (Intention to Treat)
Patient Feelings When Thinking About Being in the Hospital (Afraid/Scared, Sad/Blue, Angry; Worried)
Time frame: Hospital discharge (hospital discharge date varies by patient), 3 days post-hospital discharge, and 9-weeks post-hospital discharge), (Intention to Treat)
The Positive and Negative Affect Schedule (PANAS): Parent Measure of Child's Positive Affect
Time frame: Primary: Hospital discharge (hospital discharge date varies by patient); secondary: 3 days post-hospital discharge and 9-weeks post-hospital discharge (Intention to Treat)
The Positive and Negative Affect Schedule (PANAS): Parent Measure of Child's Negative Affect
Time frame: Primary: Hospital discharge (hospital discharge date varies by patient); secondary: 3 days post-hospital discharge and 9-weeks post-hospital discharge (Intention to Treat)
Six-item Short-form of the State Scale of the Spielberger State-Trait Anxiety Inventory (STAI)
Time frame: Immediately after first visit, (Intention to Treat)
Parent Rating of Hospital
Time frame: Primary: Hospital discharge (hospital discharge date varies by patient); secondary: 3 days post-hospital discharge and 9-weeks post-hospital discharge (Intention to Treat)
Microbial Load (Colony Forming Units; Cfu) on Hands That Touched the Dog Versus Hands of Medically Eligible Controls
Time frame: Immediately after first visit

Results and safety

Results posted to the registry on 15 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Therapy Dog Visits	12	12
Control Group	14	12
Parents of Enrolled Children Randomized to Therapy Dog Visits	9	9
Parents of Enrolled Children Randomized to the Control Group	10	9

Primary outcome: Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) Total Distress Score

Time frame: Immediately after first visit (Intention to Treat). Mean (Standard Deviation). Unit: score on a scale

Measure	Therapy Dog Visits n = 11	Control Group n = 12
Value	11.0 (12.5)	13.6 (12.8)

Therapy Dog Visits vs Control Group: Median Difference (Final Values): -3.0 (95% CI -12.4 to 6.4)

Population analysed: Two out of 14 patients randomized to the control arm did not have a visit 1; one out of 12 patients randomized to the intervention group did not complete the survey.

Primary outcome: Microbial Load (Colony Forming Units; Cfu) on Child Hands

Time frame: Immediately after first visit (Intention to Treat and Per Protocol). Mean (Standard Deviation). Unit: Colony Forming Units/mL on log10 scale

Measure	Therapy Dog Visits n = 12	Control Group n = 12
Value	3.03 (1.32)	3.39 (1.01)

Therapy Dog Visits vs Control Group: Mean Difference (Final Values): -0.04 (95% CI -0.60 to 0.52)

Population analysed: 12 intervention patients (24 hands) and 12 control patients (24 hands) \[excluding 2 control patients who did not have a visit 1\]

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: 58 days after randomization. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Therapy Dog Visits	0 of 12 (0%)	0 of 12 (0%)	2 of 12
Control Group	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Limitations and caveats (from the sponsor): The study did not meet its recruitment target and may therefore have been underpowered

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37930283Chubak J, Adler A, Bobb JF, Hawkes RJ, Ziebell RA, Pocobelli G, Ludman EJ, Zerr DM. A Randomized Controlled Trial of Animal-assisted Activities for Pediatric Oncology Patients: Psychosocial and Microbial Outcomes. J Pediatr Health Care. 2024 May-Jun;38(3):354-364. doi: 10.1016/j.pedhc.2023.09.010. Epub 2023 Nov 4.

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Therapy Dog Visit in people with Pediatric Cancer, Animal-Assisted Activities, run by Kaiser Permanente at 2 sites in United States.

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: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

Yes. Results are posted in the registry (first posted 15 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) Total Distress Score (time frame: Immediately after first visit (Intention to Treat)). 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?

On the ClinicalTrials.gov record for NCT03471221, which also lists 1 linked publication.

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 15 Jun 2026.