BreastfeedingNCT03686319
The Effect of Reflexology on Lactation and Postpartum Comfort for Cesarean-delivery Primiparous Mothers
A study testing Reflexology in people with Breastfeeding and Lactation Failure, run by Selcuk University.
Trial summary
Immediately after cesarean birth, many women suffer from breastfeeding problems due to pain, fatigue, activity intolerance, anesthesia, and delayed onset of lactation. Because of these avoidable problems, the baby cannot get enough breast milk, and mothers' postpartum comfort decreases. Read more about this study
- Who is it for?
- Ages 18 to 41 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Lactation Failure, Nursing Caries
- What is being tested?
- Reflexology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 30 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 41 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- primiparas delivering through CS,
- at the age of 18 and over,
- at ≤37 gestational weeks
- with one-fetus birth,
- with stable vital signs,
- those delivering under general anesthesia,
- except for CS and spinal/epidural anesthesia,
- with ability of communication in Turkish, and those accepting to participate into the study voluntarily.
Who cannot join
- primiparas with infectious diseases such as shingles, fungus, eczema, warts and callus in the intervention group,
- those with local infections like abscess,
- open lesion/wound, scar tissue, edema, hematoma, thrombophlebitis, deep vein thrombosis, coagulopathy, mass, varicosis, deformities on toes, recent fractures or dislocations, tearing of fascia and tendons,
- and with psychiatric disorders such as anxiety and depression, were excluded out of the study.
About this study
Official title: The Effect of Reflexology on Lactation and Postpartum Comfort for Cesarean-delivery
Immediately after cesarean birth, many women suffer from breastfeeding problems due to pain, fatigue, activity intolerance, anesthesia, and delayed onset of lactation. Because of these avoidable problems, the baby cannot get enough breast milk, and mothers' postpartum comfort decreases.
This study aimed to investigate the effect of reflexology on lactation and postpartum comfort in primiparas giving births through cesarean section.
Read the detailed description
Methods: This randomized controlled trial was conducted with 100 women with first birth through cesarean section were investigated between May 2016 and May 2017. Expectant mothers were randomly included into an intervention and a control group. The intervention group consisted of mothers for whom reflexology was performed three times per day for 30 min every eight hours.
With face-to-face interviews, all participants were informed about the design, content and methods to be used in the study, and the sociodemographic data obtained self-reportingly from the primiparas were recorded. The data were collected between May 2016 and May 2017. In collecting the data related to primiparas and infants, a questionnaire structured by the researchers in light of literature was used, as well as The breastfeeding charting system (LATCH), The visual analogue scale (VAS) for signs of onset of lactation and The postpartum comfort questionnaire (PPCQ).
- Conditions
- Breastfeeding, Lactation Failure, Nursing Caries, Postpartum, Reflexology
- Being tested
- Reflexology
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReflexologyOther
Reflexology: foot massage
| Study group | Role | What they receive |
|---|---|---|
| control groups | No intervention | Primiparas appropriate for the criteria, admitted to the clinic due to CS and accepting to participate in the study were randomly placed into groups. Reflexology was performed in the intervention group mothers, and the questionnaires and scales were self-reportingly filled in by the lead researcher (SC). Different rooms were allocated for the participants in the intervention and control groups not to affect each other. |
| "intervention" (foot reflexology) | Experimental | Reflexology was performed in those in the intervention group after CS on right foot for 10 min and left foot for 20 min as continuing 30-min seances three times per day every eight hours for three days. The procedure was started at mean 3rd hour after mothers became stable. Reflexology was performed for none of those in the control group. Receives: Other: Reflexology |
What is being measured
The primary outcome is the main question the study is designed to answer.
The breastfeeding charting system (LATCH)
As nurses are more likely to use a subjective criterion as poor /fair/ well to document and assess breastfeeding, LATCH provides a systematic method to collect information about individual breastfeeding sessions. The system is scored between 0 and 5 to indicate the key components of breastfeeding. Each breastfeeding session is assessed in light of the total score. A total score lower than 10 means that mothers are to be supported (Yenal and Okumus, 2003; Demirhan, 1997; Jensen et al., 1995). The letters of the acronym LATCH designate separate areas of assessment: ''L'' for how well infants latch onto the breast, ''A'' for the amount of audible swallowing,''T'' for mothers' nipple type, ''C'' for mothers' level of comfort, ''H'' for the amount of support given for infants to hold the breast.
Measured: Change from The breastfeeding charting system (LATCH) scores at first, second and third days after cesarean.
The visual analogue scale (VAS) for signs of onset of lactation
VAS was used to evaluate breast changes during the onset of lactation by mothers' self-reports, as in the study performed by Mauri et al. (2015). Initial signs of lactation were assessed as breast-tension, increase in breast-heat and breast-pain, and scored from 0 (no signs) to 10 (most powerful signs) (Mauri et al., 2015).
Measured: Change from The visual analogue scale (VAS) for signs of onset of lactation scores at first, second and third days after cesarean
The postpartum comfort questionnaire (PPCQ)
Constituted by Kolcaba in 1992, the General Comfort Scale (GCS) was adapted to Turkish by Kuguoglu and Karabacak in 2004 (Kuguoglu and Karabacak, 2008). Based on the Turkish version of GCS, the Postpartum Comfort Questionnaire (PPCQ) was developed by Karakaplan and Yildiz in 2010. Factor analyses were assigned to test the validity and reliability of GCS. The internal consistency in terms of reliability was tested, and the Cronbach's alpha was found as 0.78. PPCQ evaluates the physical, psychospiritual and sociocultural comfort of mothers after CS or vaginal delivery. These comfort areas also constitute the subdimensions of the scale. The scale using a 5-point Likert-type scoring includes 34 items, ranging from 5 (strongly agree) as the highest level of comfort to 1 (strongly disagree) as the lowest. Reverse coding is applied to the items with negative statements. The minimum and the maximum scores on the scale change between 34 and 170. The scores close to 170 indicate a high level of
Measured: At the end of 3rd day, The postpartum comfort questionnaire (PPCQ) was performed for all mothers.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start1 May 2016
- Primary completion1 Apr 2017
- Study completion30 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Selcuk 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seyhan Çankaya, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686319
- Sponsor's protocol ID
- 99950669/53
- Status last verified
- Sep 2018
- First submitted
- 24 Sep 2018
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reflexology on Lactation and Postpartum Comfort for Cesarean-delivery
- ClinicalTrials.gov ID
- NCT03686319
- Acronym / sponsor ID
- 99950669/53
- Conditions
- Breastfeeding, Lactation Failure, Nursing Caries, Postpartum, Reflexology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 26 Sep 2018 (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.
Immediately after cesarean birth, many women suffer from breastfeeding problems due to pain, fatigue, activity intolerance, anesthesia, and delayed onset of lactation. Because of these avoidable problems, the baby cannot get enough breast milk, and mothers' postpartum comfort decreases.
This study aimed to investigate the effect of reflexology on lactation and postpartum comfort in primiparas giving births through cesarean section.
Detailed description
Methods: This randomized controlled trial was conducted with 100 women with first birth through cesarean section were investigated between May 2016 and May 2017. Expectant mothers were randomly included into an intervention and a control group. The intervention group consisted of mothers for whom reflexology was performed three times per day for 30 min every eight hours.
With face-to-face interviews, all participants were informed about the design, content and methods to be used in the study, and the sociodemographic data obtained self-reportingly from the primiparas were recorded. The data were collected between May 2016 and May 2017. In collecting the data related to primiparas and infants, a questionnaire structured by the researchers in light of literature was used, as well as The breastfeeding charting system (LATCH), The visual analogue scale (VAS) for signs of onset of lactation and The postpartum comfort questionnaire (PPCQ).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control groups | No intervention | –Primiparas appropriate for the criteria, admitted to the clinic due to CS and accepting to participate in the study were randomly placed into groups. Reflexology was performed in the intervention group mothers, and the questionnaires and scales were self-reportingly filled in by the lead researcher (SC). Different rooms were allocated for the participants in the intervention and control groups not to affect each other. |
| "intervention" (foot reflexology) | Experimental | Other: ReflexologyReflexology was performed in those in the intervention group after CS on right foot for 10 min and left foot for 20 min as continuing 30-min seances three times per day every eight hours for three days. The procedure was started at mean 3rd hour after mothers became stable. Reflexology was performed for none of those in the control group. |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- primiparas delivering through CS,
- at the age of 18 and over,
- at ≤37 gestational weeks
- with one-fetus birth,
- with stable vital signs,
Key exclusion criteria (4 listed)
- primiparas with infectious diseases such as shingles, fungus, eczema, warts and callus in the intervention group,
- those with local infections like abscess,
- open lesion/wound, scar tissue, edema, hematoma, thrombophlebitis, deep vein thrombosis, coagulopathy, mass, varicosis, deformities on toes, recent fractures or dislocations, tearing of fascia and tendons,
- and with psychiatric disorders such as anxiety and depression, were excluded out of the study.
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 |
|---|---|---|
| ReflexologyReflexology: foot massage | Other | "intervention" (foot reflexology) |
Primary outcome
The breastfeeding charting system (LATCH)
Time frame: Change from The breastfeeding charting system (LATCH) scores at first, second and third days after cesarean.
As nurses are more likely to use a subjective criterion as poor /fair/ well to document and assess breastfeeding, LATCH provides a systematic method to collect information about individual breastfeeding sessions. The system is scored between 0 and 5 to indicate the key components of breastfeeding. Each breastfeeding session is assessed in light of the total score. A total score lower than 10 means that mothers are to be supported (Yenal and Okumus, 2003; Demirhan, 1997; Jensen et al., 1995). The letters of the acronym LATCH designate separate areas of assessment: ''L'' for how well infants latch onto the breast, ''A'' for the amount of audible swallowing,''T'' for mothers' nipple type, ''C'' for mothers' level of comfort, ''H'' for the amount of support given for infants to hold the breast.
The visual analogue scale (VAS) for signs of onset of lactation
Time frame: Change from The visual analogue scale (VAS) for signs of onset of lactation scores at first, second and third days after cesarean
VAS was used to evaluate breast changes during the onset of lactation by mothers' self-reports, as in the study performed by Mauri et al. (2015). Initial signs of lactation were assessed as breast-tension, increase in breast-heat and breast-pain, and scored from 0 (no signs) to 10 (most powerful signs) (Mauri et al., 2015).
The postpartum comfort questionnaire (PPCQ)
Time frame: At the end of 3rd day, The postpartum comfort questionnaire (PPCQ) was performed for all mothers.
Constituted by Kolcaba in 1992, the General Comfort Scale (GCS) was adapted to Turkish by Kuguoglu and Karabacak in 2004 (Kuguoglu and Karabacak, 2008). Based on the Turkish version of GCS, the Postpartum Comfort Questionnaire (PPCQ) was developed by Karakaplan and Yildiz in 2010. Factor analyses were assigned to test the validity and reliability of GCS. The internal consistency in terms of reliability was tested, and the Cronbach's alpha was found as 0.78. PPCQ evaluates the physical, psychospiritual and sociocultural comfort of mothers after CS or vaginal delivery. These comfort areas also constitute the subdimensions of the scale. The scale using a 5-point Likert-type scoring includes 34 items, ranging from 5 (strongly agree) as the highest level of comfort to 1 (strongly disagree) as the lowest. Reverse coding is applied to the items with negative statements. The minimum and the maximum scores on the scale change between 34 and 170. The scores close to 170 indicate a high level of
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Reflexology in people with Breastfeeding and Lactation Failure, run by Selcuk University.
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 8 inclusion and 4 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: finished, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The breastfeeding charting system (LATCH) (time frame: Change from The breastfeeding charting system (LATCH) scores at first, second and third days after cesarean.). 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 26 Sep 2018.