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| Name | Class |
|---|---|
| Prevent Child Abuse America | UNKNOWN |
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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.
Mothers recorded their babies fussing, crying and sleeping on paper diaries when their infants were 1, 4, 6, 8 and 12 weeks old.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Happiest Baby videotape | Experimental | videotape describing the Happiest Baby on the Block technique |
|
| control videotape | Placebo Comparator | videotape with normal newborn instruction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Happiest Baby videotape | Behavioral | a videotape demonstrating the Happiest Baby on the Block technique for calming crying infants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hours Per Day of Fuss/Cry | total hours per day of fuss, cry, and unsoothable crying. | week 8 |
| Hours Per Day of Sleep | mean sleep time is the mean of 3 daily sleep times reported in a time period. | week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week 6 |
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Inclusion Criteria:
Mothers of singleton newborns
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonna M. McRury, M.D. | University of Toledo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riverside Methodist Hospital | Columbus | Ohio | 43214 | United States |
1408 Fliers were distributed and 51 mothers contacted the research assistant for enrollment in the study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Happiest Baby Videotape | videotape describing the Happiest Baby on the Block technique |
| FG001 | Control Videotape | videotape with normal newborn instruction |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Happiest Baby Videotape | videotape describing the Happiest Baby on the Block technique |
| BG001 | Control Videotape | videotape with normal newborn instruction |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | (mothers) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | results based on ITT; 16 subjects did not complete any diaries or data collection instruments and are not included in the analysis | Posted | Mean | Standard Deviation | points on a scale | week 6 |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonna M. McRury, M.D. | University of Toledo | 419-389-1118 | jmcrury@aol.com |
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| ID | Term |
|---|---|
| D003085 | Colic |
| D003448 | Crying |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009633 | Nonverbal Communication |
| D003142 | Communication |
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| control videotape | Behavioral | a videotape with general newborn care instructions |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | (mothers) | Mean | Standard Deviation | years |
|
| Age Continuous | (babies) | Mean | Standard Deviation | days |
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| Age, Customized | (babies) | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Hours Per Day of Fuss/Cry | total hours per day of fuss, cry, and unsoothable crying. | 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 | Posted | Mean | Standard Deviation | hours per day | week 8 |
|
|
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| Primary | Hours Per Day of Sleep | mean sleep time is the mean of 3 daily sleep times reported in a time period. | Results based on ITT; 16 subjects did not complete any diaries and are not included in the analysis | Posted | Mean | Standard Deviation | hours per day | week 8 |
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| D001519 | Behavior |