Pain, LaborNCT06951750
Effect of Foot Reflexology on Postpartum Afterpains
A study testing Reflexology and general foot massage in people with Pain, Labor, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to determine the effect of foot reflexology on afterpains after normal labor. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Pain, Labor
- What is being tested?
- Reflexology and general foot massage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2025to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- They will be multipara (2-3).
- They will be normal vaginal labor
Who cannot join
- High-risk pregnancy.
- Post-partum hemorrhage.
- Neonatal birth weight over 4 kg.
- Over distension of the uterus.
- Cesarean section.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study will be conducted to determine the effect of foot reflexology on afterpains after normal labor.
Read the detailed description
Afterpains are among the most prevalent complaints after natural vaginal delivery. Non-pharmacological treatment modalities to relieve afterpains are an important care priority as they can lead to maternal and neonatal complications including anxiety, sleep disturbances, emotional disorders, depression, inability to care for the baby and continue breastfeeding, delays in early breastfeeding, reduced maternal ability to perform daily chores.
It was reported that pain in the early hours postpartum is one of the most important factors contributing to chronic postpartum pain and depression. Furthermore, pain and stress increase adrenaline release and decrease oxytocin release, thus leading to the cessation of the oxytocin reflex and disrupting breast milk production in addition to causing discomfort for the mother.
Since afterpains is a common problem that affects the physical and mental well-being of mothers, it requires the attention of healthcare providers. There is only one study that investigated the effect of reflexology on the pain level of afterpains after normal vaginal delivery. Moreover, no study investigated the effect of reflexology on either the behavioral response toward pain or the pressure pain threshold. Therefore, this study will be conducted to provide physiotherapists with updated scientific Knowledge concerning the effect of foot reflexology on afterpains after normal labor. This Study may expand the role of physiotherapy in women's health.
- Conditions
- Pain, Labor
- Being tested
- Reflexology, placebo reflexology, general foot massage
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReflexologyOther
The participants will receive two minutes of specific reflexology on each point of the uterus, pituitary, and solar plexus in the form of rotational pressures. This will be performed in the first hour post-partum and will be repeated in the second hour post-partum
placebo reflexologyOther
The participants will receive rotational pressures on a neutral point on the lateral side of the heel (placebo point) for six minutes. This will be performed in the first hour post-partum and will be repeated in the second hour post-partum
general foot massageOther
The participants will receive a general massage on each foot for four minutes. This will be performed in the first hour post-partum and will be repeated in the second hour post-partum
| Study group | Role | What they receive |
|---|---|---|
| Reflexology group | Experimental | The participants will receive reflexology on foot and on specific uterine points in the first hour post-partum and will be repeated in the second hour post-partum Receives: Other: Reflexology; Other: general foot massage |
| Placebo reflexology | Active comparator | The participants will receive reflexology on foot and on heel (placebo points) in the first hour post-partum and will be repeated in the second hour post-partum Receives: Other: placebo reflexology; Other: general foot massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain intensity
It will be used to assess pain levels in women in both groups before treatment (1 hour postpartum), after 2 hours, 3 hours and 4 hours postpartum. It comprises 16 items that reflect equally the sensory (11 items) and affective (5 items) dimensions of pain. These items were responded to by 5 points Likert-like scale as follows: 0 = none, 1= Mild, 2 = Moderate 3 =Severe, 4 = Unbearable pain. The total score will be ranged between 0 to 60 and classified as follows: No pain = 0, mild pain (from 1 to 15), moderate pain (from 16 to 30), severe pain (from 31 to 45), and unbearable pain (from 46 to 60). These pain-rating scales have shown good validity and reliability for assessing pain intensity. The intraclass correlation coefficients were 0.95
Measured: 4 hours
Modified version of chamber price pain Rating Scale
This tool was adapted for measuring any behavioral responses towards pain including 4 dimensions: Gross motor activity, posture, verbalization, and facial expression. For each dimension, one of 3 alternatives (0, 1, and 2) is to be elicited by the researcher. For posture, the alternatives are very relaxed, guarded, and tense posture. For gross motor activity, the alternatives are very restless, slightly restless, and quiet. For facial expression, alternatives are not frowning, some frowning, and constant frowning or grimacing. Lastly, women's verbalization differs between normal, no sound, groans/moans, and cries/sobs. The total score of the 4 dimensions varies between 0-8 and is categorized as follows: no pain (0) mild pain (1-2), moderate pain (3-4), severe pain (5-6), and intolerable pain (7- 8). it will be measured for both groups before treatment (1 hour postpartum), after 2 hours, 3 hours and 4 hours postpartum.
Measured: 4 hours
Pressure pain threshold (PPT):
The pressure algometer will be used to measure deep muscular tissue sensitivity for participants in both groups before treatment (1 hour postpartum), after 2 hours, 3 hours and 4 hours postpartum.. The test determines the amount of pressure over a given area in which a steadily increasing no-painful-pressure stimulus turns into a painful pressure sensation. A varying pressure is applied from 0.5 to 1 kg/sec in a perpendicular direction relative to the muscle. Six points will be determined to evaluate the PPTs. PPT recording sites will be marked out the abdomen around the umbilical scar and lumbar region as follows: Two measurements 4 cm from the umbilicus, bilaterally (points I and II), two other measurements 4 cm below the previous ones (points III and IV), a single measurement 4 cm from the lower margin of the umbilicus (point V) and another single measurement into the medial side of the lumbar region below the fifth lumbar vertebra, correspond-in to S2-S4 (point VI).
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start30 Apr 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, LaborStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Ismail Mahmoud, Cairo University
- Investigators
- Hazem El-Ashmawy, Professor, Study director, Cairo UniversityDoaa Osman, As professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951750
- Sponsor's protocol ID
- P.T.REC/012/005673
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Foot Reflexology on Postpartum Afterpains
- ClinicalTrials.gov ID
- NCT06951750
- Acronym / sponsor ID
- P.T.REC/012/005673
- Conditions
- Pain, Labor
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Apr 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted to determine the effect of foot reflexology on afterpains after normal labor.
Detailed description
Afterpains are among the most prevalent complaints after natural vaginal delivery. Non-pharmacological treatment modalities to relieve afterpains are an important care priority as they can lead to maternal and neonatal complications including anxiety, sleep disturbances, emotional disorders, depression, inability to care for the baby and continue breastfeeding, delays in early breastfeeding, reduced maternal ability to perform daily chores.
It was reported that pain in the early hours postpartum is one of the most important factors contributing to chronic postpartum pain and depression. Furthermore, pain and stress increase adrenaline release and decrease oxytocin release, thus leading to the cessation of the oxytocin reflex and disrupting breast milk production in addition to causing discomfort for the mother.
Since afterpains is a common problem that affects the physical and mental well-being of mothers, it requires the attention of healthcare providers. There is only one study that investigated the effect of reflexology on the pain level of afterpains after normal vaginal delivery. Moreover, no study investigated the effect of reflexology on either the behavioral response toward pain or the pressure pain threshold. Therefore, this study will be conducted to provide physiotherapists with updated scientific Knowledge concerning the effect of foot reflexology on afterpains after normal labor. This Study may expand the role of physiotherapy in women's health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reflexology group | Experimental | Other: Reflexology, Other: general foot massageThe participants will receive reflexology on foot and on specific uterine points in the first hour post-partum and will be repeated in the second hour post-partum |
| Placebo reflexology | Active comparator | Other: placebo reflexology, Other: general foot massageThe participants will receive reflexology on foot and on heel (placebo points) in the first hour post-partum and will be repeated in the second hour post-partum |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- They will be multipara (2-3).
- They will be normal vaginal labor
Key exclusion criteria (5 listed)
- High-risk pregnancy.
- Post-partum hemorrhage.
- Neonatal birth weight over 4 kg.
- Over distension of the uterus.
- Cesarean section.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReflexologyThe participants will receive two minutes of specific reflexology on each point of the uterus, pituitary, and solar plexus in the form of rotational pressures. This will be performed in the first hour post-partum and will be repeated in the second hour post-partum | Other | Reflexology group |
| placebo reflexologyThe participants will receive rotational pressures on a neutral point on the lateral side of the heel (placebo point) for six minutes. This will be performed in the first hour post-partum and will be repeated in the second hour post-partum | Other | Placebo reflexology |
| general foot massageThe participants will receive a general massage on each foot for four minutes. This will be performed in the first hour post-partum and will be repeated in the second hour post-partum | Other | Placebo reflexology, Reflexology group |
Primary outcome
Assessment of pain intensity
Time frame: 4 hours
It will be used to assess pain levels in women in both groups before treatment (1 hour postpartum), after 2 hours, 3 hours and 4 hours postpartum. It comprises 16 items that reflect equally the sensory (11 items) and affective (5 items) dimensions of pain. These items were responded to by 5 points Likert-like scale as follows: 0 = none, 1= Mild, 2 = Moderate 3 =Severe, 4 = Unbearable pain. The total score will be ranged between 0 to 60 and classified as follows: No pain = 0, mild pain (from 1 to 15), moderate pain (from 16 to 30), severe pain (from 31 to 45), and unbearable pain (from 46 to 60). These pain-rating scales have shown good validity and reliability for assessing pain intensity. The intraclass correlation coefficients were 0.95
Modified version of chamber price pain Rating Scale
Time frame: 4 hours
This tool was adapted for measuring any behavioral responses towards pain including 4 dimensions: Gross motor activity, posture, verbalization, and facial expression. For each dimension, one of 3 alternatives (0, 1, and 2) is to be elicited by the researcher. For posture, the alternatives are very relaxed, guarded, and tense posture. For gross motor activity, the alternatives are very restless, slightly restless, and quiet. For facial expression, alternatives are not frowning, some frowning, and constant frowning or grimacing. Lastly, women's verbalization differs between normal, no sound, groans/moans, and cries/sobs. The total score of the 4 dimensions varies between 0-8 and is categorized as follows: no pain (0) mild pain (1-2), moderate pain (3-4), severe pain (5-6), and intolerable pain (7- 8). it will be measured for both groups before treatment (1 hour postpartum), after 2 hours, 3 hours and 4 hours postpartum.
Pressure pain threshold (PPT):
Time frame: 4 hours
The pressure algometer will be used to measure deep muscular tissue sensitivity for participants in both groups before treatment (1 hour postpartum), after 2 hours, 3 hours and 4 hours postpartum.. The test determines the amount of pressure over a given area in which a steadily increasing no-painful-pressure stimulus turns into a painful pressure sensation. A varying pressure is applied from 0.5 to 1 kg/sec in a perpendicular direction relative to the muscle. Six points will be determined to evaluate the PPTs. PPT recording sites will be marked out the abdomen around the umbilical scar and lumbar region as follows: Two measurements 4 cm from the umbilicus, bilaterally (points I and II), two other measurements 4 cm below the previous ones (points III and IV), a single measurement 4 cm from the lower margin of the umbilicus (point V) and another single measurement into the medial side of the lumbar region below the fifth lumbar vertebra, correspond-in to S2-S4 (point VI).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hazem El-Ashmawy, Professor study director
Cairo University
Doaa Osman, As professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reflexology and general foot massage in people with Pain, Labor, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hala I Mahmoud, Master (01116341936, maryamsamma@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pain intensity (time frame: 4 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.