Physiotherapeutic Protocol Compared to Usual Care in the Treatment of Postpartum Primiparas After Perineal Trauma: A Type 1 Hybrid Effectiveness-Implementation Randomized Controlled Trial With Economic Evaluation
Phase: NA
Conditions: Episiotomy, Lacerations Perineal, Obstetric Anal Sphincter Injury, Perineal Injury, Perineal Laceration, Tear, or Rupture During Delivery, Perineal Pain, Perineal Tear Resulting From Childbirth, Perineal Tear and Episiotomy
Sponsor: University of Sao Paulo

 
 
 
 
LABORATÓRIO DE AVALIAÇÃO FUNCIONAL DOS MÚSCULOS DO ASSOALHO PÉLVICO 
 
 
PHD PROJECT 
 
Physiotherapeutic protocol compared to usual care in the treatment of postpartum 
primiparas after perineal trauma: a type 1 hybrid effectiveness-implementation 
randomized controlled trial with economic evaluation  
 
 
 
 
 
Ribeirão Preto – SP 
July 11, 2025 
 

The intervention group will receive the following interventions  
 
During hospitalization: 
1.​ Information: on physiotherapy in women's health, pelvic floor muscles (PFM) and 
their dysfunctions, using educational materials and images, as well as guidance on the 
care to be taken during hospitalization (guidance on postures to be adopted or 
avoided, breathing control, load management, and intimate hygiene). 
2.​ Contraction of the Pelvic Floor Muscles (PFMC): PFMCwill be carried out during 
hospitalization with the aim of observing the participant's ability to contract and 
advising on the correct way to contract according to visual feedback. The participant 
will be asked to perform 10 light contractions of the pelvic floor muscles at the limit 
of her pain tolerance in the supine position, with her knees bent and her feet on the 
bed, without palpation. Phrases such as "hold your pee", "close your vagina with the 
strength of your pelvic floor muscles" and "don't contract any other muscles or hold 
your breath" will be used to explain the movement to be performed. 
3.​ Cryotherapy: 1 session of 20 minutes of application of an ice pack prepared by the 
researcher responsible for the intervention. The ice pack will consist of a 15 cm 
plastic bag with 150g of crushed ice, weighed on a scale in order to adapt it to the 
female genital anatomy. The ice pack will be wrapped in a thin cotton cloth to avoid 
direct contact with the skin. After positioning the ice, the participant will be asked to 
put her underwear back on, keeping the bag in the appropriate position. The 
temperature of the perineal region will be measured during the application in three 
time periods: immediately before cryotherapy, ten minutes after the start of 
cryotherapy and at the end of cryotherapy. The thermometer used will be a Minipa 
brand, which is portable, has a laser sight and does not come into direct contact with 
the participant's skin, thus avoiding contamination. 
 
After hospitalization: at home 
1.​ Pelvic Floor Muscle Training (PFMT): PFMT at home will consist of a total of 12 
weekly online sessions and will be divided into two time periods: up to 40 days after 
childbirth, which will be carried out with the aim of controlling inflammation; after 40 
days after childbirth, which will be carried out with the aim of strengthening the 
muscles. Therefore, with the participant in the supine position, knees bent and feet on 
the bed, she will be asked to perform, under supervision:  

-​
Up to 40 days after childbirth (7 sessions): 3 sets of 10 quick, light 
contractions of the pelvic floor muscles at the limit of pain tolerance, with 
2-minute rest intervals between sets; 
-​
From 40 days after delivery (5 sessions): 3 sets of 10 maximum contractions 
sustained for 6 seconds followed by 10 rapid maximum contractions; 2-minute 
rest intervals between sets. 
Guidance will also be provided to carry out the training daily at home, with 
the same protocol and without supervision. The frequency of PFMT at home will be 
monitored by a researcher not involved in the training or evaluation, and will be 
recorded. 
2.​ Cryotherapy: Participants will be instructed to apply ice packs for pain relief. The 
number of applications and pain before and after (NRS) will be recorded.  
 
 
The control group will receive the usual care provided by the maternity ward at 
Hospital das Clínicas de Ribeirão Preto, which consists of suturing the injury and 
administering oral analgesics. 
 
 
 

TIDieR evaluation  
 
Item 
number 
Item 
Physiotherapy Protocol  
Control 
 
SUMMARY NAME 
 
 
1. 
Provide a name or a phrase that 
describes the intervention 
Combined pelvic floor muscle training 
(PFMT) protocol associated with 
cryotherapy, guidance and information 
Usual maternity care 
 
WHY 
 
 
2. 
Describe any justification, 
theory or objective of the 
essential elements of the 
intervention. 
Cryotherapy can relieve pain, and 
TMAP is able to minimize sexual 
dysfunction and the functional 
consequences of perineal trauma 
The usual maternity care includes 
analgesic medication to help 
relieve pain 
 
WHAT  
 
 
3. 
Materials: Describe all physical 
or informational materials used 
in the intervention, including 
those provided to participants or 
used in the execution of the 
intervention or in the training of 
those responsible for the 
intervention. Provide 
information on where the 
materials can be accessed (e.g. 
online appendix, URL). 
Ice pack, which will consist of a 15 cm 
plastic bag containing 150 g of crushed 
ice, wrapped in a fine cotton mesh and 
informative images about the anatomy 
and function of the pelvic floor muscles.  
Not applicable 
4. 
Procedures: Describe each of the 
procedures, activities and/or 
processes used in the 
intervention, including any 
enabling or supporting activities. 
During hospitalization: the participants 
will receive information on 
physiotherapy in women's health, PFM 
and its dysfunctions, as well as guidance 
on the care to be taken; contraction of 
the pelvic floor muscles with the aim of 
observing the participant's ability to 
contract and providing guidance on the 
correct way to contract according to 
visual feedback. The participant will be 
asked to perform 10 light contractions 
of the pelvic floor muscles at the limit 
of pain tolerance in the supine position, 
with her knees bent and feet on the bed, 
without palpation; 20 minutes of ice 
pack application which will be wrapped 
in a thin cotton cloth to avoid direct 
contact with the skin. After placing the 
ice, the participant will be asked to put 
her underwear back on, keeping the bag 
in the appropriate position. The 
temperature of the perineal region will 
be measured during the application in 
three time periods: immediately before 
cryotherapy, ten minutes after the start 
of cryotherapy and at the end of 
cryotherapy 
After hospitalization (at home): 12 
weekly online sessions and will be 
During hospitalization, women will 
receive individual doses of 
analgesic medication (e.g. 
Dipyrone) when they complain of 
pain in the perineal region.  
After discharge, these patients will 
be advised to use the same 
medication, with the doses 
indicated by the maternity doctors, 
in cases of pain in the perineal 
region. 

divided into two time periods: up to 40 
days after delivery, which will be 
carried out with the aim of controlling 
inflammation; after 40 days after 
delivery, which will be carried out with 
the aim of strengthening the muscles. 
Therefore, with the participant in the 
supine position, knees bent and feet on 
the bed, she will be asked to perform, 
under supervision:  
Up to 40 days after childbirth (7 
sessions): 3 sets of 10 quick, light 
contractions of the pelvic floor muscles 
at the limit of pain tolerance, with 
2-minute rest intervals between sets; 
From 40 days after delivery (5 
sessions): 3 sets of 10 maximum 
contractions sustained for 6 seconds 
followed by 10 rapid maximum 
contractions; 2-minute rest intervals 
between sets. 
Guidance will also be provided to carry 
out the training daily at home, with the 
same protocol and without supervision. 
The frequency of TMAP at home will 
be monitored by a researcher not 
involved in the training or evaluation, 
and will be recorded. 
The participants will be instructed to 
apply ice packs for pain relief. The 
number of applications and pain before 
and after will be recorded.  
 
WHO SUPPLIED 
 
 
5.  
For each category of 
professional responsible for the 
intervention (e.g. psychologist, 
nursing assistant), describe their 
skills, background and the 
specific training they have 
received. 
A physiotherapist with around 2 years' 
experience in women's health 
physiotherapy  
Doctor hired by the maternity ward 
of the Hospital das Clínicas de 
Ribeirão Preto (HC-FMRP) 
 
HOW 
 
 
6.  
Describe how the intervention 
was carried out (e.g. face-to-face 
or via other means such as the 
Internet or telephone) and 
whether it was carried out 
individually or in groups. 
An individual face-to-face session 
supervised during hospitalization. 
After hospitalization, TMAP will be 
carried out through weekly online 
sessions and the application of the ice 
pack will be unsupervised. 
Face-to-face and individually 
supervised during hospitalization. 
After hospitalization, the use of 
medication will be unsupervised. 
 
WHERE 
 
 
7.  
Describe the type(s) of site(s) 
where the intervention took 
place, including any necessary 
infrastructure or relevant 
features. 
During hospitalization at HCFMRP and 
after hospitalization at home, the latter 
requiring internet access and a device 
with internet access, such as a cell 
phone or computer. 
During hospitalization at HCFMRP 
and after hospitalization at home. 
 
WHEN and HOW MUCH 
 
 

8.  
Describe the number of times the 
intervention was carried out and 
over what period of time, 
including the number of 
sessions, the schedule, the 
duration, the intensity or the 
dose. 
The participants will receive 1 
physiotherapy session during 
hospitalization, with 20 minutes of 
cryotherapy and MAP contraction 
training.  
After hospitalization, the participants 
will receive 12 weekly TMAP sessions 
and will apply ice packs as needed (the 
number of applications will be 
recorded). 
According to the participant's 
needs and complaints 
 
ADAPTATION 
 
 
9.  
If the intervention was planned 
to be personalized, regulated or 
adapted, describe what, why, 
when and how. 
Some aspects of the intervention will be 
personalized for each participant, such 
as the number of ice pack applications at 
home. 
This will be determined by the 
participant's pain. The application of ice 
packs at home will be advised to the 
participants as a non-pharmacological 
method for the relief of perineal pain. 
The use of analgesic medication 
will be personalized according to 
the participant's pain complaints, 
during hospitalization and at home. 
 
MODIFICATIONS 
 
 
10. 
If the intervention was modified 
during the study, describe the 
changes (what, why, when and 
how). 
No changes are planned during the 
protocol, however, if the patient does 
not feel comfortable or wishes to stop 
applying ice or muscle contractions, as 
well as TMAP during the online 
sessions, her wishes will be respected 
and the changes will be recorded 
Not applicable 
 
QUALITY 
 
 
11. 
Expected: If adherence or 
fidelity to the intervention was 
evaluated, describe how and by 
whom, and if strategies were 
used to maintain or improve 
fidelity, describe them. 
Acceptability, suitability, feasibility, 
adherence and satisfaction with the 
proposed protocol will be assessed by 
the investigator in charge of the 
evaluations 
Adherence and compliance will be 
assessed using a medication diary  
12. 
Current: If adherence or fidelity 
to the intervention was assessed, 
describe the extent to which the 
intervention was carried out as 
planned. 
Not applicable 
Not applicable