Effectiveness of Physiotherapy Interventions in the Management of Breastfeeding Difficulties After Instrumental Births: A Clinical Study (FisioLac)

# Detailed Description

## Background and Rationale

Breastfeeding requires coordinated oral, facial, cranial, and cervical musculoskeletal function in the infant. Effective breastfeeding depends on appropriate positioning, attachment, sucking, and swallowing, as well as maternal comfort during feeding.

Infants born following instrumental vaginal delivery, including forceps-assisted or vacuum-assisted delivery, may experience musculoskeletal alterations affecting the cranio-cervical and orofacial regions. These alterations may contribute to difficulties with breastfeeding positioning, attachment, sucking, and feeding effectiveness.

Manual physiotherapy targeting infant musculoskeletal function may provide an additional therapeutic approach alongside conventional breastfeeding support. Further randomized controlled trials are needed to evaluate its effectiveness using standardized breastfeeding assessments and quantitative measures of cervical mobility.

• Study Objectives

The primary objective is to determine whether manual physiotherapy, in addition to conventional breastfeeding support, improves breastfeeding performance compared with conventional breastfeeding support alone in mother-infant dyads experiencing breastfeeding difficulties following instrumental vaginal delivery.

The primary outcome will be the change in the Bristol Breastfeeding Assessment Tool (BBAT) total score from baseline (Day 0) to Day 37.

Secondary objectives include evaluating changes in infant cervical range of motion, maternal pain intensity during breastfeeding, and infant irritability; assessing clinical changes at Days 15 and 30; and evaluating subsequent outcomes when the infant reaches six months of chronological age.

## Study Design

This study is a prospective, randomized, controlled clinical trial with two parallel groups, blinded outcome assessment, and blinded statistical analysis.

A total of 126 mother-infant dyads will be recruited, with 63 participants allocated to each study group.

Eligible infants must have been born following instrumental vaginal delivery, including forceps-assisted or vacuum-assisted delivery, and must be no older than three months at enrollment.

Participants will be randomly assigned in a 1:1 ratio to the experimental or control group using a computer-generated randomization sequence.

The experimental group will receive six sessions of manual physiotherapy, delivered approximately once weekly, in addition to conventional breastfeeding support and a home exercise program.

The control group will receive conventional breastfeeding support and a home exercise program without the study-specific manual physiotherapy intervention.

Clinical outcome assessments will be conducted at five time points:

• T0: Day 0, baseline.
• T1: Day 15, intermediate assessment.
• T2: Day 30, intermediate assessment.
• T3: Day 37, primary endpoint.
• T4: When the infant reaches six months of chronological age.

Days 0, 15, 30, and 37 will be calculated individually from each participant's baseline date. The six-month follow-up assessment will be scheduled according to the infant's date of birth.

Recruitment is planned from November 1 to December 31, 2026.

## Blinding and Bias Minimization

An independent physiotherapist, blinded to treatment allocation, will perform all outcome assessments in both study groups.

A second physiotherapist will administer the manual physiotherapy intervention to infants in the experimental group and will not participate in outcome assessment.

At visits coinciding with treatment sessions, the blinded outcome assessor will complete all clinical assessments before the treating physiotherapist administers the intervention.

Due to the nature of the intervention, the treating physiotherapist and participating families cannot be blinded. Families will be instructed not to disclose their treatment allocation to the blinded assessor.

Statistical analyses will be conducted by a statistician who is a member of the research team but will remain blinded to treatment allocation.

The statistician will receive a coded dataset identifying the study groups using neutral labels, such as Group A and Group B, without disclosure of which group received manual physiotherapy.

The allocation code will remain concealed until the prespecified statistical analyses have been completed and the results finalized.

## Study Population and Recruitment

The study population will consist of mother-infant dyads experiencing breastfeeding difficulties following instrumental vaginal delivery.

Only infants born through forceps-assisted or vacuum-assisted vaginal delivery will be eligible.

Infants must be no older than three months of chronological age at enrollment.

The infant's date of birth and exact postnatal age at enrollment will be recorded.

Written informed consent will be obtained from parents or legal guardians before participation.

• Eligibility Criteria

  • Inclusion Criteria

    - Mother-infant dyads experiencing breastfeeding difficulties.

    - Infants born following instrumental vaginal delivery using forceps or vacuum extraction.

    - Infants aged three months or younger at enrollment.

    - Infants born at term, at or after 37 completed weeks of gestation.

    • Mothers intending to establish or maintain exclusive breastfeeding.
    • Written informed consent provided by a parent or legal guardian.

  • Exclusion Criteria

    - Infants diagnosed with ankyloglossia.

    • Infants with diagnosed neurological syndromes.
    • Infants with medical conditions that contraindicate the planned intervention or prevent reliable clinical assessment.

• Breastfeeding Performance Assessment

Breastfeeding performance will be assessed using the Bristol Breastfeeding Assessment Tool (BBAT).

The BBAT evaluates four components of breastfeeding: positioning, attachment, sucking, and swallowing.

Each component is scored from 0 to 2, producing a total score ranging from 0 to 8. Higher scores indicate better breastfeeding performance.

The primary endpoint will be the between-group difference in the change in BBAT total score from baseline (Day 0) to Day 37.

The assessment will be performed during an observed breastfeeding session by the independent physiotherapist blinded to treatment allocation.

Additional BBAT assessments will be conducted at Days 15 and 30 and when the infant reaches six months of chronological age, provided that a breastfeeding session can be observed.

## Infant Cervical Range of Motion Assessment

Infant cervical range of motion will be assessed using the Baiobit motion measurement system.

Measurements will include right and left cervical rotation and right and left cervical lateral flexion, recorded in degrees.

A standardized measurement procedure adapted to infant age and clinical condition will be established before recruitment, including positioning, device placement, measurement conditions, and safety precautions.

Assessments will be performed at Days 0, 15, 30, and 37 and at six months of infant age.

## Maternal Pain Assessment

Maternal pain intensity during breastfeeding will be assessed using a 100-mm Visual Analog Scale (VAS), ranging from 0 mm (no pain) to 100 mm (worst imaginable pain).

Immediately after the observed breastfeeding session, the mother will indicate the intensity of pain experienced during that specific feeding.

The score will be recorded in millimeters, with higher scores indicating greater pain intensity.

Assessments will be performed at Days 0, 15, 30, and 37 and at six months of infant age when breastfeeding can be observed.

## Infant Irritability Assessment

Infant irritability will be assessed through maternal reporting.

Persistent crying lasting at least three hours per day will be considered in the assessment.

Irritability will be recorded as a dichotomous variable (yes/no).

Assessments will be performed at Days 0, 15, 30, and 37 and when the infant reaches six months of age.

## Study Interventions

### Control Group: Conventional Breastfeeding Support

Mother-infant dyads allocated to the control group will receive individualized conventional breastfeeding support, including guidance on breastfeeding positioning, infant attachment, maternal comfort, and feeding effectiveness.

Parents will also receive instructions for a home exercise program according to the study protocol.

The control group will not receive the study-specific manual physiotherapy intervention.

No scheduled telephone follow-up calls will be included.

• Experimental Group: Manual Physiotherapy and Conventional Breastfeeding Support

Mother-infant dyads allocated to the experimental group will receive the same conventional breastfeeding support and home exercise guidance as the control group.

In addition, infants will receive six manual physiotherapy sessions delivered approximately once weekly.

The intervention will include:

• General myofascial techniques targeting cranio-cervical, respiratory, digestive, and musculoskeletal regions.
• Gentle manual techniques applied to abdominal and mesenteric regions.
• Gentle joint mobility techniques involving the spine, shoulder and pelvic girdles, and rib cage.
• Manual techniques targeting muscle tone and myotatic reflex responses.
• Gentle sustained-pressure techniques applied to cervical, suprahyoid, and infrahyoid muscles.
• Manual stimulation techniques targeting anatomical regions associated with cranial nerves involved in oral motor function and swallowing.

All techniques will be adapted to the infant's clinical condition and tolerance and performed by a qualified physiotherapist trained in the study protocol.

The treating physiotherapist will not participate in outcome assessment.

## Treatment and Assessment Schedule

The experimental group will follow the schedule below:

• Day 0: Baseline assessment (T0), followed by manual physiotherapy session 1.
• Day 7: Manual physiotherapy session 2.
• Day 15: Intermediate assessment (T1), followed by manual physiotherapy session 3.
• Day 22: Manual physiotherapy session 4.
• Day 30: Intermediate assessment (T2), followed by manual physiotherapy session 5.
• Day 37: Primary endpoint assessment (T3), followed by manual physiotherapy session 6.
• At six months of infant age: Follow-up assessment (T4).

The intervals between treatment sessions will be approximately seven to eight days.

On Days 0, 15, 30, and 37, the blinded outcome assessor will complete all clinical assessments before the treating physiotherapist administers the scheduled manual physiotherapy session.

Participants in the control group will undergo the same clinical assessments on Days 0, 15, 30, and 37 and at six months of infant age, without receiving the study-specific manual physiotherapy intervention.

The primary outcome will be assessed on Day 37, immediately before the sixth and final manual physiotherapy session.

## Outcome Measures

### Primary Outcome

**Change in Breastfeeding Performance Assessed by the Bristol Breastfeeding Assessment Tool (BBAT)**

Breastfeeding performance will be measured using the BBAT total score, ranging from 0 to 8 points, with higher scores indicating better breastfeeding performance.

The primary endpoint will be the between-group difference in the change in BBAT total score from baseline to Day 37.

Time Frame: Baseline (Day 0) and Day 37.

### Secondary Outcomes

**1. Change in Infant Cervical Range of Motion**

Right and left cervical rotation and lateral flexion will be measured in degrees using the Baiobit motion measurement system.

Time Frame: Baseline (Day 0), Days 15, 30, and 37, and six months of infant age.

**2. Change in Maternal Pain Intensity During Breastfeeding**

Maternal pain intensity will be measured using a 100-mm Visual Analog Scale (VAS).

The assessment will refer specifically to pain experienced during the observed breastfeeding session.

Time Frame: Baseline (Day 0), Days 15, 30, and 37, and six months of infant age when breastfeeding can be observed.

**3. Change in Infant Irritability**

Infant irritability will be assessed through maternal reporting and recorded as a dichotomous variable (yes/no).

Persistent crying lasting at least three hours per day will be considered in the assessment.

Time Frame: Baseline (Day 0), Days 15, 30, and 37, and six months of infant age.

**4. Breastfeeding Performance at Intermediate and Follow-up Assessments**

BBAT total scores will also be assessed at Days 15 and 30 and when the infant reaches six months of chronological age, provided that breastfeeding can be observed.

Time Frame: Days 15 and 30 and six months of infant age.

## Statistical Analysis

The primary analysis will compare the change in BBAT total score from baseline (Day 0) to Day 37 between the experimental and control groups.

An appropriate statistical model will be used to estimate the treatment effect and its 95% confidence interval, taking into account baseline BBAT score and the bounded nature of the outcome scale.

Secondary longitudinal analyses will assess BBAT scores at Days 15 and 30 and at the six-month follow-up, where available.

Changes in infant cervical range of motion and maternal pain intensity measured using the VAS will be analyzed using appropriate models for repeated measurements.

Infant irritability will be analyzed using statistical methods appropriate for repeated binary outcomes.

The infant's postnatal age at enrollment will be recorded and considered as a potential covariate because participants may enter the study at different ages.

Missing data and reasons for unavailable assessments will be documented, particularly when breastfeeding cannot be observed at the six-month follow-up.

The prespecified statistical analyses will be conducted by a statistician blinded to treatment allocation. The treatment code will be revealed only after these analyses have been finalized.

## Ethical Considerations

The study protocol will be submitted to the appropriate Research Ethics Committee for approval before recruitment begins.

Written informed consent will be obtained from parents or legal guardians before enrollment.

Participation will be voluntary, and families may withdraw at any time without affecting access to usual healthcare.

Adverse events and unexpected responses associated with the intervention will be documented and managed according to the approved study protocol.

## Study Significance

This randomized controlled trial will evaluate whether manual physiotherapy improves breastfeeding performance in infants aged three months or younger who experience breastfeeding difficulties following instrumental vaginal delivery.

The primary endpoint at Day 37 will allow comparison of changes in breastfeeding performance between the experimental and control groups near completion of the intervention period.

Secondary assessments will provide information about cervical mobility, maternal pain, and infant irritability, while the six-month follow-up will allow evaluation of subsequent clinical outcomes.

The use of blinded outcome assessment and blinded statistical analysis is intended to strengthen the methodological quality of the study.