Osteopathic treatment of infants with infantile colic/excessive crying: a prospective, multicentric, randomized controlled trial and nested observational trial
Abstract Background Colic in infants is defined as excessive crying in an otherwise healthy and thriving baby. Colic is a common but poorly understood and often frustrating problem for caregivers. Objective To study whether osteopathic treatments of infants with infantile colic / excessive crying (I...
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2025-01-01
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| Series: | BMC Pediatrics |
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| Online Access: | https://doi.org/10.1186/s12887-025-05413-1 |
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| author | Florian Schwerla Marlen Zimmer Janine Göpfert Petra Laux Simone Langenmair Michaela Rütz Karl-Ludwig Resch |
| author_facet | Florian Schwerla Marlen Zimmer Janine Göpfert Petra Laux Simone Langenmair Michaela Rütz Karl-Ludwig Resch |
| author_sort | Florian Schwerla |
| collection | DOAJ |
| description | Abstract Background Colic in infants is defined as excessive crying in an otherwise healthy and thriving baby. Colic is a common but poorly understood and often frustrating problem for caregivers. Objective To study whether osteopathic treatments of infants with infantile colic / excessive crying (IC/EC) have an impact on the subjectively perceived psychological stress of caregivers compared to usual care. Methods The study was designed as a prospective, multicenter, randomized controlled trial. Infants aged 1 week to 3 months and who met Rome IV criteria for IC/EC were included. By means of external randomization, infants were allocated to an intervention group or a control group. Infants in the intervention group received three osteopathic treatments at intervals of one weeks. The treatments were custom-tailored and based on osteopathic principles. Controls received their osteopathic treatment after a 3 week untreated period. The primary outcome parameter was the assessment of parental psychological stress (three questions), measured using a numeric rating scale (NRS; 0–10). Furthermore, the average daily crying time (measured using the Likert scale), the crying intensity (measured using the NRS) and the parents' self-confidence (measured using the Karitane Parenting Confidence Scale) were assessed. Results A total of 103 infants (average age 39.4 ±19.2 days) were included, 52 in the intervention group and 51 in the control group. An inter-group comparison of changes revealed clinically relevant improvements in favor of the intervention group for the main outcome – parameter psychological stress – for all 3 questions (e.g., for question 2 respectively 3, NRS: between group difference of means 3.5; 95% CI: 2.6 to 4.4; p < 0.001). For the secondary outcome parameters of crying intensity and crying time/day, the changes were of similar magnitude. Conclusion Three osteopathic treatments given over a period of two weeks led to statistically significant and clinically relevant positive changes of parental psychological stress. Trial registration German Clinical Trials Register: DRKS00025867, registration date 10.08.21. |
| format | Article |
| id | doaj-art-e75d79e162ee4494adf6d15320ef5a80 |
| institution | Kabale University |
| issn | 1471-2431 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Pediatrics |
| spelling | doaj-art-e75d79e162ee4494adf6d15320ef5a802025-02-02T12:42:55ZengBMCBMC Pediatrics1471-24312025-01-0125111310.1186/s12887-025-05413-1Osteopathic treatment of infants with infantile colic/excessive crying: a prospective, multicentric, randomized controlled trial and nested observational trialFlorian Schwerla0Marlen Zimmer1Janine Göpfert2Petra Laux3Simone Langenmair4Michaela Rütz5Karl-Ludwig Resch6German Academy of Osteopathy, Research CommissionOsteopathic PracticeOsteopathic PracticeOsteopathic PracticeOsteopathic PracticeGerman Academy of Osteopathy, Research CommissionGerman Institute for Health Research (DIG)Abstract Background Colic in infants is defined as excessive crying in an otherwise healthy and thriving baby. Colic is a common but poorly understood and often frustrating problem for caregivers. Objective To study whether osteopathic treatments of infants with infantile colic / excessive crying (IC/EC) have an impact on the subjectively perceived psychological stress of caregivers compared to usual care. Methods The study was designed as a prospective, multicenter, randomized controlled trial. Infants aged 1 week to 3 months and who met Rome IV criteria for IC/EC were included. By means of external randomization, infants were allocated to an intervention group or a control group. Infants in the intervention group received three osteopathic treatments at intervals of one weeks. The treatments were custom-tailored and based on osteopathic principles. Controls received their osteopathic treatment after a 3 week untreated period. The primary outcome parameter was the assessment of parental psychological stress (three questions), measured using a numeric rating scale (NRS; 0–10). Furthermore, the average daily crying time (measured using the Likert scale), the crying intensity (measured using the NRS) and the parents' self-confidence (measured using the Karitane Parenting Confidence Scale) were assessed. Results A total of 103 infants (average age 39.4 ±19.2 days) were included, 52 in the intervention group and 51 in the control group. An inter-group comparison of changes revealed clinically relevant improvements in favor of the intervention group for the main outcome – parameter psychological stress – for all 3 questions (e.g., for question 2 respectively 3, NRS: between group difference of means 3.5; 95% CI: 2.6 to 4.4; p < 0.001). For the secondary outcome parameters of crying intensity and crying time/day, the changes were of similar magnitude. Conclusion Three osteopathic treatments given over a period of two weeks led to statistically significant and clinically relevant positive changes of parental psychological stress. Trial registration German Clinical Trials Register: DRKS00025867, registration date 10.08.21.https://doi.org/10.1186/s12887-025-05413-1Osteopathic medicineOMTInfantsInfantile colicExcessive crying |
| spellingShingle | Florian Schwerla Marlen Zimmer Janine Göpfert Petra Laux Simone Langenmair Michaela Rütz Karl-Ludwig Resch Osteopathic treatment of infants with infantile colic/excessive crying: a prospective, multicentric, randomized controlled trial and nested observational trial BMC Pediatrics Osteopathic medicine OMT Infants Infantile colic Excessive crying |
| title | Osteopathic treatment of infants with infantile colic/excessive crying: a prospective, multicentric, randomized controlled trial and nested observational trial |
| title_full | Osteopathic treatment of infants with infantile colic/excessive crying: a prospective, multicentric, randomized controlled trial and nested observational trial |
| title_fullStr | Osteopathic treatment of infants with infantile colic/excessive crying: a prospective, multicentric, randomized controlled trial and nested observational trial |
| title_full_unstemmed | Osteopathic treatment of infants with infantile colic/excessive crying: a prospective, multicentric, randomized controlled trial and nested observational trial |
| title_short | Osteopathic treatment of infants with infantile colic/excessive crying: a prospective, multicentric, randomized controlled trial and nested observational trial |
| title_sort | osteopathic treatment of infants with infantile colic excessive crying a prospective multicentric randomized controlled trial and nested observational trial |
| topic | Osteopathic medicine OMT Infants Infantile colic Excessive crying |
| url | https://doi.org/10.1186/s12887-025-05413-1 |
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