Touch-based treatments and infantile colic - Parental perceptions of treatment outcomes
| ISRCTN | ISRCTN15640779 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15640779 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | HUS-2351-2020-7, HEL 2020-012399 T 13 02 01 |
| Sponsor | Helsinki Metropolia University of Applied Sciences |
| Funders | Child and Nature Foundation, Jenny and Antti Wihuri Foundation |
- Submission date
- 15/05/2025
- Registration date
- 19/05/2025
- Last edited
- 21/11/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Infantile colic is a common condition affecting many newborns, characterized by excessive crying and discomfort, often without a clear cause. This study aims to evaluate the effectiveness of different touch-based therapies—osteopathy, reflexology, and affective touch—in alleviating colic symptoms in infants.
Who can participate?
The study includes full-term infants aged 10 weeks or younger at the time of recruitment who exhibit symptoms consistent with colic, such as prolonged periods of crying. Parents or legal guardians must provide informed consent for their child's participation.
What does the study involve?
Participating infants were allocated to one of four groups—osteopathy, reflexology, affective touch, or standard care provided by child health clinic nurses—using a non-randomised assignment procedure.
Each intervention consists of multiple sessions over a period of 2–3 weeks. Parents are asked to maintain symptom diaries and complete questionnaires to report on their infant's crying patterns, sleep quality, and overall well-being. Additionally, some parents participate in semi-structured interviews to share their experiences with the assigned therapy.
What are the possible benefits and risks of participating?
Potential benefits include a reduction in colic symptoms, improved sleep patterns for the infant, and decreased parental stress. As the interventions are non-invasive and administered by trained professionals, risks are minimal. However, there may be a possibility that the therapy does not alleviate symptoms for all participants.
Where is the study run from?
The study recruitment is conducted in public child health clinics in Helsinki, the interventions are coordinated from the Metropolia University of Applied Sciences campus (Finland).
When is the study starting and how long is it expected to run for?
January 2020 to October 2022
Who is funding the study?
The study is funded by the Child and Nature Foundation and the Jenny and Antti Wihuri Foundation (Finland)
Who is the main contact?
Tiina Väänänen, tiina.vaananen@tuni.fi
Contact information
Scientific, Principal investigator
PL 4000
00079 Metropolia
Helsinki / Finland
Helsinki
00079
Finland
| Phone | +358 (0)974245000 |
|---|---|
| leena.hannula@metropolia.fi |
Public
Pobox 4000
00079 Metropolia
Helsinki
00079
Finland
| Phone | +358 (0)401591759 |
|---|---|
| sandra.rinne@metropolia.fi |
Scientific
Salastintie 66
Ruokolahti
56210
Finland
| Phone | +358 (0)500764350 |
|---|---|
| tiina.vaananen@tuni.fi |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre mixed-methods interventional non-randomized single-blinded study |
| Secondary study design | Non randomised study |
| Participant information sheet | 47352_PIS_Parents_14Oct20.pdf |
| Scientific title | Touch-based treatments and infantile colic - Parental perceptions of treatment outcomes |
| Study objectives | Our hypotheses were that: 1. Osteopathy and reflexology have a greater effect in reducing parent-reported infant crying hours and increasing the parent-reported infant sleeping hours than conventional care alone (H1a) 2. Affective touch has a greater effect in reducing these parent-reported colic symptoms than conventional care alone (H1b), osteopathy and reflexology are more effective than affective touch (H2) Our research questions were: 1. What effects do osteopathic treatment and reflexology have on infant colic symptoms, such as crying and sleep, as assessed by parents and practitioners, compared to affective touch or conventional child health clinic care only? 2. How do osteopathy and reflexology, in comparison to affective touch or conventional child health clinic care only, affect parental stress and fatigue, according to parents' self-reported experience? 3. How do parents perceive the benefits and usability of osteopathy and reflexology during and after the colic phase, in comparison to affective touch or conventional child health clinic care only? |
| Ethics approval(s) |
1. Approved 28/10/2020, HUS ethical committee (HUS Tutkimuseettinen toimikunta PL 705, Helsinki, 000290, Finland; +358 (0)40 359 4618; eettinen.toimikunta@hus.fi), ref: HUS/2351/2020 2. Approved 08/01/2021, City of Helsinki (Pohjoisesplanadi 11-13, Helsinki, 00099, Finland; +358 (0)310 13700; tutkimusluvat.sote@hel.fi), ref: HEL 2020-012399 T 13 02 01 3. Approved 01/11/2021, City of Vantaa (Vantaan kaupungin kirjaamo, PL 1100, Vantaa, 01030, Finland; +358 (0)983911; kirjaamo@vantaa.fi), ref: VD/10228/13.00.00/2021 |
| Health condition(s) or problem(s) studied | Infantile colic |
| Intervention | 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 nurses. Each infant received one type of touch-based intervention, delivered by trained professionals or nurses over a series of sessions. Parents were instructed to observe and report outcomes such as crying, sleep, and overall well-being. All participating infants received three free-of-charge treatments over a 2- to 3-week period at the treatment centre of Metropolia University. Each appointment for osteopathy, reflexology, and affective touch lasted a full hour, including time for discussion and breaks. The manual procedure itself lasted approximately 20–30 minutes. Four follow-up questionnaires were sent to the osteopathy, reflexology and affective touch group parents: before the beginning of the experimental treatments (T0), within a day after the first treatment (T1), 1 week after the third treatment (T2) and 4 weeks after final treatment of the intervention (T3). Conventional care group parents were sent questionnaires T0, T2 and T3 at the same time points. The duration for treatment was 2-3 weeks and the follow-up lasted 4 weeks after the treatments, totalling a 7-week period. |
| Intervention type | Other |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
1. Infant crying time is measured using parent-reported structured diaries in hours per day at T0, T2, and T3 |
| Completion date | 31/10/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 0 Days |
| Upper age limit | 10 Weeks |
| Sex | All |
| Target sample size at registration | 200 |
| Total final enrolment | 177 |
| Key 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) |
| Key exclusion criteria | 1. Preterm infants (gestational age <37 weeks) 2. Infants with additional medical diagnoses |
| Date of first enrolment | 15/02/2021 |
| Date of final enrolment | 30/10/2022 |
Locations
Countries of recruitment
- Finland
Study participating centre
Helsinki
00920
Finland
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository |
| IPD sharing plan | The research data of the project will be retained by stored on Metropolia University's secure online disk for as long as necessary for the analysis and reporting of the research data and for five years after the end of the study until 2028. Manual data (consent forms and symptom diaries) will be disposed of appropriately in the shredder of the data protection container. After the study has been completed, when identifying information has been removed from the literature and the survey data has been anonymized, the data can be handed over for storage, for example, to the tietoarkisto.fi (Data Archive) https://www.fsd.tuni.fi/fi/. Data type: De-identified individual participant data (IPD), including parent-reported symptom diaries, questionnaire responses, and relevant demographic information. Availability: Data will be accessible starting six months after the publication of the final study results and will remain available for a period of five years. Access criteria: Researchers interested in accessing the data must submit a formal request to the principal investigator, including a brief proposal outlining the intended use of the data. Mechanism: Upon approval of the request, a data sharing agreement will be established to ensure compliance with ethical standards and data protection regulations. Consent and anonymization: Participants' legal guardians provided informed consent for the use of de-identified data in future research. All shared data will be anonymized to protect participant confidentiality. Ethical considerations: Data sharing will adhere to applicable ethical guidelines and legal requirements, ensuring that the rights and privacy of participants are safeguarded. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 19/11/2025 | 21/11/2025 | Yes | No | |
| Participant information sheet | version 3 | 14/10/2020 | 19/05/2025 | No | Yes |
| Participant information sheet | 18/09/2020 | 19/05/2025 | No | Yes | |
| Participant information sheet | 18/09/2020 | 19/05/2025 | No | Yes | |
| Protocol file | version 3 | 15/10/2020 | 19/05/2025 | No | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 47352_PIS_Parents_14Oct20.pdf
- Participant information sheet
- 47352_PROTOCOL_V3_15Oct20.pdf
- Protocol file
- 47352_PIS_18Sep20.pdf
- Participant information sheet
- 47352_PIS_18Sep20 2.pdf
- Participant information sheet
Editorial Notes
21/11/2025: Publication reference added.
16/05/2025: Trial's existence confirmed by HUS ethical committee.
