Colic
Conditions
Keywords
colic, crying, clinical trial
Brief summary
This is a study looking at the Happiest Baby on the Block technique. The investigators hypothesized that infants of mothers given a 30 minute videotape demonstrating the Happiest Baby on the Block technique would fuss/cry less and sleep longer than infants of mothers given a 30 minute videotape on general newborn care. The investigators also hypothesized that mothers given the Happiest Baby on the Block videotape would have lower levels of stress.
Detailed description
Mothers recorded their babies fussing, crying and sleeping on paper diaries when their infants were 1, 4, 6, 8 and 12 weeks old.
Interventions
BEHAVIORALHappiest Baby videotape
a videotape demonstrating the Happiest Baby on the Block technique for calming crying infants
BEHAVIORALcontrol videotape
a videotape with general newborn care instructions
Sponsors
Prevent Child Abuse America
Riverside Methodist Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 5 Days
Healthy volunteers
Yes
Inclusion criteria
Mothers of singleton newborns * 37 to 41 week gestation * healthy (no ICU admission)
Exclusion criteria
* not able to view videotape at home * not able to speak English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hours Per Day of Fuss/Cry | week 8 | total hours per day of fuss, cry, and unsoothable crying. |
| Hours Per Day of Sleep | week 8 | mean sleep time is the mean of 3 daily sleep times reported in a time period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parenting Stress Index | week 6 | a continuous scale measuring stress with a range of 131 (low) to 320 (high); the average person's stress scores are between 188 and 252. |
Countries
United States
Participant flow
Recruitment details
Mothers of healthy singleton newborn infants with a gestational age of 37-41 weeks admitted to the normal newborn nursery of a large community hospital were given a flier inviting them to participate by contacting the research assistant by phone.
Pre-assignment details
1408 Fliers were distributed and 51 mothers contacted the research assistant for enrollment in the study.
Participants by arm
| Arm | Count |
|---|---|
| Happiest Baby Videotape videotape describing the Happiest Baby on the Block technique | 27 |
| Control Videotape videotape with normal newborn instruction | 24 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 7 |
Baseline characteristics
| Characteristic | Happiest Baby Videotape | Control Videotape | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 24 Participants | 51 Participants |
| Age Continuous | 29 years STANDARD_DEVIATION 6 | 30 years STANDARD_DEVIATION 4 | 3 days STANDARD_DEVIATION 1 |
| Age, Customized <=5 days | 27 participants | 24 participants | 51 participants |
| Age, Customized >5 days | 0 participants | 0 participants | 0 participants |
| Region of Enrollment United States | 27 participants | 24 participants | 51 participants |
| Sex: Female, Male Female | 27 Participants | 24 Participants | 51 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Outcome results
Primary
Hours Per Day of Fuss/Cry
total hours per day of fuss, cry, and unsoothable crying.
Time frame: week 8
Population: If fewer than 3 diaries were completed for a given time period (that is, one or two of the days was missing or had more than 180 minutes unrecorded), then the average of only the completed diaries was used. Results are based on ITT; 16 subjects did not complete any diaries and are not included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Happiest Baby Videotape | Hours Per Day of Fuss/Cry | 2.20 hours per day | Standard Deviation 1.25 |
| Control Videotape | Hours Per Day of Fuss/Cry | 1.48 hours per day | Standard Deviation 1.23 |
Primary
Hours Per Day of Sleep
mean sleep time is the mean of 3 daily sleep times reported in a time period.
Time frame: week 8
Population: Results based on ITT; 16 subjects did not complete any diaries and are not included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Happiest Baby Videotape | Hours Per Day of Sleep | 13.87 hours per day | Standard Deviation 1.6 |
| Control Videotape | Hours Per Day of Sleep | 14.1 hours per day | Standard Deviation 1.73 |
Secondary
Parenting Stress Index
a continuous scale measuring stress with a range of 131 (low) to 320 (high); the average person's stress scores are between 188 and 252.
Time frame: week 6
Population: results based on ITT; 16 subjects did not complete any diaries or data collection instruments and are not included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Happiest Baby Videotape | Parenting Stress Index | 225.3 points on a scale | Standard Deviation 35.3 |
| Control Videotape | Parenting Stress Index | 188.9 points on a scale | Standard Deviation 27.9 |