Effectiveness of Physiotherapy Interventions in the Management of Breastfeeding Difficulties After Instrumental Births: A Clinical Study
NCT07926126, Not applicable, Not yet recruiting, Fundacion Miguel Servet
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effectiveness of Physiotherapy Interventions in the Management of Breastfeeding Difficulties After Instrumental Births: A Clinical Study | ClinicalTrials.gov |
| NCT number | NCT07926126 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 126 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Fundacion Miguel Servet | ClinicalTrials.gov |
| Conditions | Breastfeading, Physiotherapy, Difficulties, Pain, Baby Massage, Manual Theapy | ClinicalTrials.gov |
| Interventions | Pediatric Manual Physiotherapy, Conventional Breastfeeding Support and Home Exercises | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change from Baseline in Bristol Breastfeeding Assessment Tool. Total Score at Day 37 | Baseline (Day 0) and Day 37 | Breastfeeding performance will be assessed using the Bristol Breastfeeding Assessment Tool (BBAT), which evaluates four components: positioning, attachment, sucking, and swallowing. Each component is scored from 0 to 2, resulting in a total score ranging from 0 to 8 points. A score of 0 indicates the greatest breastfeeding difficulties, while a score of 8 indicates the best breastfeeding performance. Higher scores indicate better breastfeeding performance. The primary outcome is the change in total BBAT score from baseline (Day 0) to Day 37, compared between the experimental and control groups. A positive change indicates improvement in breastfeeding performance. | ClinicalTrials.gov |
| Primary | Change from Baseline in Infant Cervical Range of Motion at Day 37 | Baseline (Day 0) and Day 37 | Infant cervical range of motion will be measured in degrees using the Baiobit motion analysis device. Cervical rotation to the right and left and lateral flexion to the right and left will be assessed separately. For each movement direction, change from baseline to Day 37 will be calculated as the Day 37 measurement minus the baseline measurement. Positive change values indicate an increase in cervical range of motion. Measurements will be reported in degrees (°). | ClinicalTrials.gov |
| Primary | Change from Baseline in Maternal Breastfeeding Pain Assessed by the Visual Analog Scale (VAS) at Day 37 | Baseline (Day 0) and Day 37 | Maternal pain associated with breastfeeding will be assessed using a 100-mm Visual Analog Scale (VAS) immediately after an observed breastfeeding session. The scale ranges from 0 mm (no pain) to 100 mm (worst imaginable pain). Higher scores indicate greater pain intensity. Change from baseline to Day 37 will be calculated as the Day 37 score minus the baseline score. Negative change values indicate a reduction in maternal pain. | ClinicalTrials.gov |
| Secondary | Change from Baseline in the Proportion of Infants with Irritability at Day 37 | Baseline (Day 0) and Day 37 | Infant irritability will be assessed through maternal report using a binary (Yes/No) measure. Irritability will be defined as persistent crying for three or more hours per day. Infants meeting this criterion will be classified as having irritability (Yes), while those not meeting the criterion will be classified as not having irritability (No). The proportion of infants with irritability will be compared between the experimental and control groups at baseline and Day 37. | ClinicalTrials.gov |
| Secondary | Proportion of Infants Receiving Any Breastfeeding at Six Months of Age | At six months of chronological age | Breastfeeding status will be assessed when the infant reaches six months of chronological age, calculated from the date of birth. Mothers will report whether their infant is receiving any breast milk at the time of assessment. Infants will be classified as receiving any breastfeeding (Yes) or not receiving breastfeeding (No). The proportion of infants receiving any breastfeeding will be compared between the experimental and control groups. | ClinicalTrials.gov |
| Secondary | Change from Baseline in Right Cervical Rotation Range of Motion at Day 37 | Baseline (Day 0) and Day 37 | Infant cervical rotation to the right will be measured in degrees using the Baiobit motion analysis device. The change from baseline to Day 37 will be calculated as the Day 37 measurement minus the baseline measurement. Positive change values indicate an increase in right cervical rotation range of motion. | ClinicalTrials.gov |
| Secondary | Change from Baseline in Left Cervical Rotation Range of Motion at Day 37 | Baseline (Day 0) and Day 37 | Infant cervical rotation to the left will be measured in degrees using the Baiobit motion analysis device. The change from baseline to Day 37 will be calculated as the Day 37 measurement minus the baseline measurement. Positive change values indicate an increase in left cervical rotation range of motion. | ClinicalTrials.gov |
| Secondary | Change from Baseline in Right Cervical Lateral Flexion Range of Motion at Day 37 | Baseline (Day 0) and Day 37 | Infant cervical lateral flexion to the right will be measured in degrees using the Baiobit motion analysis device. The change from baseline to Day 37 will be calculated as the Day 37 measurement minus the baseline measurement. Positive change values indicate an increase in right cervical lateral flexion range of motion. | ClinicalTrials.gov |
| Secondary | Change from Baseline in Left Cervical Lateral Flexion Range of Motion at Day 37 | Baseline (Day 0) and Day 37 | Infant cervical lateral flexion to the left will be measured in degrees using the Baiobit motion analysis device. The change from baseline to Day 37 will be calculated as the Day 37 measurement minus the baseline measurement. Positive change values indicate an increase in left cervical lateral flexion range of motion. | ClinicalTrials.gov |
| Secondary | Maternal Breastfeeding Pain Assessed by the Visual Analog Scale (VAS) at Infant Age Six Months | At six months of infant chronological age (calculated from date of birth) | Maternal pain associated with breastfeeding will be assessed using a 100-mm Visual Analog Scale (VAS) immediately after an observed breastfeeding session when the infant reaches six months of chronological age. The scale ranges from 0 mm (no pain) to 100 mm (worst imaginable pain). Higher scores indicate greater pain intensity. The VAS score will be recorded only when a breastfeeding session can be observed. Mothers who are no longer breastfeeding will not be assigned a VAS pain score. Maternal pain scores at six months of infant age will be compared between the experimental and control groups. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)