Trial Outcomes & Findings for Animal Assisted Interactions With Animal Robot in the Intensive Care Unit (ICU) (NCT NCT05075395)

Results Overview

The scale shows a series of faces ranging from a happy face at 0 which represents "no hurt" to a crying face at 10 which represents "hurts worst." Based on the faces and descriptions, the patient chooses the face that best describes their level of pain.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

19 participants

Primary outcome timeframe

Baseline measures data recorded within ten minutes prior to the therapy session, outcome measure data recorded within ten minutes after each therapy session and an average of the after-therapy session scores was record.

Results posted on

2024-12-16

Participant Flow

pediatric Intensive Care Unite (PICU) patients from a single tertiary medical center

Participant milestones

Participant milestones
Measure	Intervention The Physical Therapy/Occupational Therapy (PT/OT) provider will assess whether the patient meets eligibility criteria. If the patient is eligible to participate, they will then introduce the study to the patient and their parent or guardian. If the patient is interested in participating, the PI or PIs research assistant (RA) will seek written informed consent. After informed consent is obtained, the PI or RA will begin pretest data collection. Then, the PT/OT provider will begin the therapy session with Paro. The PI or RA will remain in the room during therapy session to record field notes. When the therapy session is complete, the PI or RA will begin post-test data collection. The patient will remain in the study for up to 7 PT/OT sessions or until they are discharged from the Pediatric Intensive Care Unite (PICU). The PT/OT providers will coordinate all subsequent therapy sessions with the PI/RA while the patient remains on the study protocol. PARO therapy seal: PARO, a baby harp seal, is an advanced interactive, therapeutic medical robot developed by AIST, a leading Japanese industrial automation pioneer. It allows the documented benefits of animal therapy to be administered to patients in environments such as hospitals and extended care facilities where live animals present treatment or logistical difficulties.
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Two participants did not complete the baseline measure for pain score

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=19 Participants The PT/OT provider will assess whether the patient meets eligibility criteria. If the patient is eligible to participate, they will then introduce the study to the patient and their parent or guardian. If the patient is interested in participating, the PI or PIs research assistant (RA) will seek written informed consent. After informed consent is obtained, the PI or RA will begin pretest data collection. Then, the PT/OT provider will begin the therapy session with Paro. The PI or RA will remain in the room during therapy session to record field notes. When the therapy session is complete, the PI or RA will begin posttest data collection. The patient will remain in the study for up to 7 PT/OT sessions or until they are discharged from the PICU. The PT/OT providers will coordinate all subsequent therapy sessions with the PI/RA while the patient remains on the study protocol. PARO therapy seal: PARO, a baby harp seal, is an advanced interactive, therapeutic medical robot developed by AIST, a leading Japanese industrial automation pioneer. It allows the documented benefits of animal therapy to be administered to patients in environments such as hospitals and extended care facilities where live animals present treatment or logistical difficulties.
Age, Categorical <=18 years	19 Participants n=19 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=19 Participants
Age, Categorical >=65 years	0 Participants n=19 Participants
Age, Continuous	11.37 years STANDARD_DEVIATION 3.905 • n=19 Participants
Sex: Female, Male Female	6 Participants n=19 Participants
Sex: Female, Male Male	13 Participants n=19 Participants
Race/Ethnicity, Customized African-American	4 Participants n=19 Participants
Race/Ethnicity, Customized Caucasian	11 Participants n=19 Participants
Race/Ethnicity, Customized Hispanic	4 Participants n=19 Participants
Region of Enrollment United States	19 Participants n=19 Participants
Pain: Wrong-Baker FACES Pain Rating Scale	3.94 Scores on a scale STANDARD_DEVIATION 3.455 • n=17 Participants • Two participants did not complete the baseline measure for pain score
Children's Anxiety Meter-State (CAM-S)	2.88 units on a scale STANDARD_DEVIATION 2.419 • n=16 Participants • 3 participants did not complete the baseline score for anxiety
Physiologic Variables- Heart Rate	102 beats per minute n=19 Participants
Physiologic Variables- Blood Pressure Systolic	118 Millimeters of mercury (mm Hg) n=19 Participants
Physiologic Variables- Blood Pressure Diastolic	70 Millimeters of mercury (mm Hg) n=19 Participants
Physiologic Variables- Respiratory Rate	22 breaths per minute n=19 Participants
Physiologic Variables- Oxygen	96 percentage of blood oxygen saturated n=19 Participants

PRIMARY outcome

Timeframe: Baseline measures data recorded within ten minutes prior to the therapy session, outcome measure data recorded within ten minutes after each therapy session and an average of the after-therapy session scores was record.

The scale shows a series of faces ranging from a happy face at 0 which represents "no hurt" to a crying face at 10 which represents "hurts worst." Based on the faces and descriptions, the patient chooses the face that best describes their level of pain.

Outcome measures

Outcome measures
Measure	Intervention n=17 Participants The PT/OT provider will assess whether the patient meets eligibility criteria. If the patient is eligible to participate, they will then introduce the study to the patient and their parent or guardian. If the patient is interested in participating, the PI or PIs research assistant (RA) will seek written informed consent. After informed consent is obtained, the PI or RA will begin pretest data collection. Then, the PT/OT provider will begin the therapy session with Paro. The PI or RA will remain in the room during therapy session to record field notes. When the therapy session is complete, the PI or RA will begin posttest data collection. The patient will remain in the study for up to 7 PT/OT sessions or until they are discharged from the PICU. The PT/OT providers will coordinate all subsequent therapy sessions with the PI/RA while the patient remains on the study protocol. PARO therapy seal: PARO, a baby harp seal, is an advanced interactive, therapeutic medical robot developed by AIST, a leading Japanese industrial automation pioneer. It allows the documented benefits of animal therapy to be administered to patients in environments such as hospitals and extended care facilities where live animals present treatment or logistical difficulties.
Pain: Wrong-Baker FACES Pain Rating Scale	3.94 units on a scale Standard Deviation 3.455

PRIMARY outcome

Timeframe: Baseline measures data recorded within ten minutes prior to the therapy session, outcome measure data recorded within ten minutes after each therapy session and an average of the after-therapy session scores was recorded.

The CAM scale is drawn to resemble a thermometer with a bulb at the bottom and horizontal lines at intervals going up to the top. Children are instructed to "Pretend that all of your worried or nervous feelings are in the very bottom down here. If you are a little bit worried or nervous, the feelings might come up just a little bit. If you are very, very worried or nervous, the feelings might go all the way to the top. Put a line showing how much worry or nervousness you feel." The range is 0 to 10 with 0 being no worry and 10 being the highest.