Infantile colic Digestive System
Conditions
Interventions
The study compared four intervention groups for infantile colic: (1) osteopathic treatment, (2) reflexology, (3) affective touch, and (4) child health clinic care only provided by child health clinic
Sponsors
Helsinki Metropolia University of Applied Sciences
Eligibility
Sex/Gender
All
Age
0 Days to 10 Weeks
Inclusion criteria
Inclusion criteria: 1. Full-term infants (gestational age =37 weeks) 2. Aged 10 weeks or younger at the time of recruitment 3. Presence of infantile colic symptoms, defined as crying for more than 3 hours per day, at least 3 days per week, consistent with Wessel's criteria. 4. Written informed consent obtained from parent(s) or legal guardian(s)
Exclusion criteria
Exclusion criteria: 1. Preterm infants (gestational age <37 weeks) 2. Infants with additional medical diagnoses
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Infant crying and sleeping patterns are measured using structured symptom diaries and questionnaires completed by parents at T0, T1, T2, and T3 for intervention groups and at T0, T2, and T3 for the conventional care group 2. Parental stress levels are measured using validated self-report questionnaires at T0, T1, T2, and T3 for intervention groups and at T0, T2, and T3 for the conventional care group 3. Parental fatigue levels are measured using validated self-report questionnaires at T0, T1, T2, and T3 for intervention groups and at T0, T2, and T3 for the conventional care group 4. Infant sleep duration and quality are measured using structured sleep diaries and questionnaires completed by parents at T0, T1, T2, and T3 for intervention groups and at T0, T2, and T3 for the conventional care group 5. Parental perceptions of the benefits and usability of the assigned intervention are measured using post-intervention surveys at T3 for all groups | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Infant crying time is measured using parent-reported structured diaries in hours per day at T0, T2, and T3 2. Infant sleeping time is measured using parent-reported structured diaries in hours per day at T0, T2, and T3 3. Parent-perceived effectiveness of the intervention in reducing infant crying and improving sleep quality is measured using parent self-assessment questionnaires at T2 and T3 4. Parental post-natal stress is measured using the Postnatal Stress Questionnaire (Park et al. 2015) at T0, T2, and T3 5. Parenting-related stress is measured using the Parenting Stress Index Short Form (Berry and Jones 1995) at T0, T2, and T3 6. Perceived general stress is measured using the Perceived Stress Scale (Cohen 1983) at T0, T2, and T3 7. Infant colic symptoms are measured using parent-reported symptom diaries and questionnaires covering the preceding 24 hours and preceding week at T0, T2, and T3 8. Parental experiences of therapeutic touch are measured using semi-structured interviews analyzed with thematic analysis at T3 | — |
Countries
Finland
Contacts
Public ContactSandra Rinne
Outcome results
None listed