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Trial Outcomes & Findings for Massage for Pediatric Oncology (NCT NCT00843180)

NCT ID: NCT00843180

Last Updated: 2012-05-08

Results Overview

days of pain \>3 by nurses notes based on pain scores on numeric rating scale (up to 28 days)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

7 days pre to 21 days post transplant = 28 days

Results posted on

2012-05-08

Participant Flow

November 2008-November 2009, 12 months UCSF Children's Hospital, Bone Marrow Transplant Unit

consecutive enrollment of all eligible admitted children. 2 teenage boys declined participation

Participant milestones

Participant milestones
Measure
Massage
massage and acupressure up to 3x/week for entire hospital stay
Control
usual care only as control arm hospital care during bone marrow transplant
Overall Study
STARTED
16
7
Overall Study
COMPLETED
16
7
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Massage for Pediatric Oncology

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Massage
n=16 Participants
massage and acupressure up to 3x/week for entire hospital stay
Control
n=7 Participants
usual care only as control arm hospital care during bone marrow transplant
Total
n=23 Participants
Total of all reporting groups
Age, Categorical
<=18 years
16 Participants
n=93 Participants
7 Participants
n=4 Participants
23 Participants
n=27 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Categorical
>=65 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age Continuous
10.9 years
STANDARD_DEVIATION 3.7 • n=93 Participants
13.7 years
STANDARD_DEVIATION 4.3 • n=4 Participants
11.7 years
STANDARD_DEVIATION 4.0 • n=27 Participants
Sex: Female, Male
Female
7 Participants
n=93 Participants
3 Participants
n=4 Participants
10 Participants
n=27 Participants
Sex: Female, Male
Male
9 Participants
n=93 Participants
4 Participants
n=4 Participants
13 Participants
n=27 Participants
Region of Enrollment
United States
16 participants
n=93 Participants
7 participants
n=4 Participants
23 participants
n=27 Participants

PRIMARY outcome

Timeframe: 7 days pre to 21 days post transplant = 28 days

Population: ITT no imputations

days of pain \>3 by nurses notes based on pain scores on numeric rating scale (up to 28 days)

Outcome measures

Outcome measures
Measure
Massage
n=16 Participants
Control
n=7 Participants
Number of Days With Pain Scores >3 Measured on Numeric Rating Scale (Range 0-10; 0 for no Pain; 10 for Worst Pain Imaginable)
7.7 days
95% Confidence Interval 4.9 • Interval 5.2 to 10.2
8.3 days
95% Confidence Interval 5.5 • Interval 2.8 to 13.7

SECONDARY outcome

Timeframe: day -7 to +21 around transplant date

Population: ITT

number of vomiting episodes as reported by nurses per occurence (no upper limit)

Outcome measures

Outcome measures
Measure
Massage
n=16 Participants
Control
n=7 Participants
Number of Vomiting Episodes
4.6 number of episodes
Interval 2.0 to 7.3
7.0 number of episodes
Interval 3.0 to 11.0

SECONDARY outcome

Timeframe: days of hospital stay after bone marrow transplant

Population: ITT

days of hospital stay after bone marrow transplant (up to 100 days; participant observation was censored after 100 days)

Outcome measures

Outcome measures
Measure
Massage
n=16 Participants
Control
n=7 Participants
Days of Hospital Stay
39.1 number of days
Interval 24.8 to 53.3
35.3 number of days
Interval 2.1 to 68.4

SECONDARY outcome

Timeframe: hospital stay

number of days to recovery neutrophil count \>500 cells per microliter for 2 consecutive days (range, up to 100 days, censored at 100 days)

Outcome measures

Outcome measures
Measure
Massage
n=16 Participants
Control
n=7 Participants
Days to Recovery Neutrophil Count
16.8 number of days
95% Confidence Interval 14.3 • Interval 14.3 to 19.4
18.7 number of days
Interval 7.3 to 30.0

Adverse Events

Massage

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Wolf Mehling, MD

UCSF

Phone: 415-353 9506

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place