Breast FeedingNCT04924439
Effects of Reflexology on Postpartum Pain, Fatigue, Sleep Quality and Lactation
A study testing foot reflexology in people with Breast Feeding and Fatigue, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
The aim of this research is to determine the effect of foot reflexology applied to primiparous women who had cesarean section in the postpartum period on pain, fatigue, sleep quality and lactation. This research is a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 19 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding, Fatigue, Sleep
- What is being tested?
- foot reflexology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 31 Jan 2021
- 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 19 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caesarean section,
- Primipary,
- 19 and over and under 35
- Literate,
- 37 and above pregnancy week
- Giving birth singularly,
Show all 11Show fewer
- Having spinal anesthesia
- No chronic disease or pregnancy complication,
- Have no breast-related health problems
- Have not had an operation related to the breast,
- Women who do not have any health problems in the feet of the mothers in the treatment group
Who cannot join
- The baby has died or is not present,
- Multiparous,
- Women with health problems in their feet
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep University Health Sciences Enstitutes
Gaziantep, 27000
About this study
Official title: Effects Reflexology on Postpartum Pain, Fatigue, Sleep Quality and Lactation
The aim of this research is to determine the effect of foot reflexology applied to primiparous women who had cesarean section in the postpartum period on pain, fatigue, sleep quality and lactation. This research is a randomized controlled trial. The study was conducted in Şanlıurfa, which has the highest fertility rate in Turkey.
Read the detailed description
The aim of this research is to determine the effect of foot reflexology applied to primiparous women who had cesarean section in the postpartum period on pain, fatigue, sleep quality and lactation. This research is a randomized controlled trial. The study was conducted in Şanlıurfa, which has the highest fertility rate in Turkey. The sample of the research consisted of 80 primiparous women (reflexology group: 40 and control group: 40). The data were collected between 01 January 2020 - 31 January 2021. "Introductory Information Form", "Visual Analogue Scale" for Pain, "Visual Analog Scale for Fatigue", "Pittsburg Sleep Quality Index" and "Bristol Breastfeeding Assessment Tool" were used as data collection tools. Foot reflexology was applied to the experimental group for 40 minutes (left foot 20 minutes and right foot 20 minutes) once a week for postpartum 8 weeks. The control group was only watched. In the intergroup comparison of the experimental and control groups, chi-square for categorical variables and independent groups t-test for numerical variables were used. Two-way repeated measures ANOVA test was performed in terms of time and group interaction in repeated measurements
- Conditions
- Breast Feeding, Fatigue, Sleep, Pain, Postoperative
- Being tested
- foot reflexology
- Keywords
- fatigue, lactation, pain, postpartum, sleep quality, reflexology
- Medical subject headings
- Breast Feeding, Fatigue, Pain, Postoperative, Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foot reflexologyOther
Foot reflexology was applied to the experimental group for 40 minutes once a week for postpartum 8 weeks. The control group was only watched.
| Study group | Role | What they receive |
|---|---|---|
| experimental group (foot reflexology group) | Experimental | 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.
Foot reflexology was applied to the experimental group for 40 minutes once a week for postpartum 8 weeks. Receives: Other: foot reflexology |
| control group | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
The scale developed by Huskisson (1974) is used for pain assessment in musculoskeletal system and other clinical assessments. VAS is used to convert some values that cannot be measured numerically to numeric. It is a frequently used measurement tool because it is easy and safe to apply. The words "I have no pain" on the left end of the 10 cm long horizontal line and "I have pain" on the right end. The individual is asked to mark the point on this horizontal line that best expresses the severity of pain in his body. The distance from the point marked by the individual to the left end is measured and the pain score is determined. It is evaluated that the severity of the pain increases as the VAS value approaches 10, and decreases as it approaches 0. The lowest 0 and the highest 10 points are taken from the scale.
Measured: Change from Visual Analogue Scale (VAS) scores at first, second, third, fourth, fifth, sixth, seventh and eighth week after cesarean. ]
Visual Similarity Scale for Fatigue (YSSF)
It is in the form of a 10 cm ruler with the most positive statements on one end of the scale and the most negative statements on the other. The most positive expression of the fatigue sub-dimension is 0, the most negative expression is 10, the most negative expression of the energy sub-dimension is 0, and the most positive expression is 10. A high score of the fatigue sub-dimension and a low score of the energy sub-dimension indicate a high severity of fatigue. The calculation method of the scale is determined by adding up all the scores obtained from the scale items. The lowest score for YSSF is 0, and the highest score is 180. The lowest score for the YSSF fatigue sub-dimension is 0, and the highest score is 130. The lowest score is 0 for the energy sub-dimension of YSSF and the highest score is 50. The scale does not have a cut-off point.
Measured: Change from Visual Similarity Scale for Fatigue (YSSF) scores at first, second, third, fourth, fifth, sixth, seventh and eighth week after cesarean. ]
Pittsburg Sleep Quality Index (PSQI)
In order to evaluate the sleep quality in the last month, Buysse et al. (1989) is a quantitative measure of sleep quality as good and bad sleep. Its Turkish adaptation was done by Ağargün et al. (1996), Cronbach's α internal consistency coefficient is 0.80. It consists of a total of 24 questions and 7 sub-components. 18 items and 7 sub-components are included in the scoring. Each item is evaluated as 0-3 points and the sum of 7 sub-components forms the PSQI score. The lowest score of the scale is 0 and the highest score is 21. A total PSQI score of ≤5 indicates good sleep, and >5 indicates poor sleep.
Measured: Change from Pittsburg Sleep Quality Index (PSQI) scores at first, fourth and eighth week after cesarean. ]
Bristol Breastfeeding Assessment Tool (BBAT)
Each item in the scoring of the scale is between 0-2 points. The calculation method is the sum of all scores obtained from the scale items. The lowest score obtained from the scale is 0, and the highest score is 8. The scale does not have a breakpoint. A low score indicates that breastfeeding is ineffective, and a high score indicates that breastfeeding is effective.
Measured: Change from Bristol Breastfeeding Assessment Tool (BBAT) scores at first, second, third, fourth, fifth, sixth, seventh and eighth week after cesarean. ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start1 Jan 2020
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- 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
- Model description
- randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysegul Kilicli, University of Gaziantep
- Investigators
- simge zeyneloğlu, proffessor, Study director, GAZİANTEP UNİVERSİTY CLINICAL RESEARCH ETHICS COMMITTE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924439
- Sponsor's protocol ID
- reflexology and cesarean
- Status last verified
- Jun 2021
- First submitted
- 3 Jun 2021
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Reflexology on Postpartum Pain, Fatigue, Sleep Quality and Lactation
- ClinicalTrials.gov ID
- NCT04924439
- Acronym / sponsor ID
- reflexology and cesarean
- Conditions
- Breast Feeding, Fatigue, Sleep, Pain, Postoperative
- Keywords
- fatigue, lactation, pain, postpartum, sleep quality, reflexology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 14 Jun 2021 (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.
The aim of this research is to determine the effect of foot reflexology applied to primiparous women who had cesarean section in the postpartum period on pain, fatigue, sleep quality and lactation. This research is a randomized controlled trial. The study was conducted in Şanlıurfa, which has the highest fertility rate in Turkey.
Detailed description
The aim of this research is to determine the effect of foot reflexology applied to primiparous women who had cesarean section in the postpartum period on pain, fatigue, sleep quality and lactation. This research is a randomized controlled trial. The study was conducted in Şanlıurfa, which has the highest fertility rate in Turkey. The sample of the research consisted of 80 primiparous women (reflexology group: 40 and control group: 40). The data were collected between 01 January 2020 - 31 January 2021. "Introductory Information Form", "Visual Analogue Scale" for Pain, "Visual Analog Scale for Fatigue", "Pittsburg Sleep Quality Index" and "Bristol Breastfeeding Assessment Tool" were used as data collection tools. Foot reflexology was applied to the experimental group for 40 minutes (left foot 20 minutes and right foot 20 minutes) once a week for postpartum 8 weeks. The control group was only watched. In the intergroup comparison of the experimental and control groups, chi-square for categorical variables and independent groups t-test for numerical variables were used. Two-way repeated measures ANOVA test was performed in terms of time and group interaction in repeated measurements
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| experimental group (foot reflexology group) | Experimental | Other: foot reflexologyPrimiparas 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. Foot reflexology was applied to the experimental group for 40 minutes once a week for postpartum 8 weeks. |
| control group | 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. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Caesarean section,
- Primipary,
- 19 and over and under 35
- Literate,
- 37 and above pregnancy week
Key exclusion criteria (3 listed)
- The baby has died or is not present,
- Multiparous,
- Women with health problems in their feet
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 |
|---|---|---|
| foot reflexologyFoot reflexology was applied to the experimental group for 40 minutes once a week for postpartum 8 weeks. The control group was only watched. | Other | experimental group (foot reflexology group) |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: Change from Visual Analogue Scale (VAS) scores at first, second, third, fourth, fifth, sixth, seventh and eighth week after cesarean. ]
The scale developed by Huskisson (1974) is used for pain assessment in musculoskeletal system and other clinical assessments. VAS is used to convert some values that cannot be measured numerically to numeric. It is a frequently used measurement tool because it is easy and safe to apply. The words "I have no pain" on the left end of the 10 cm long horizontal line and "I have pain" on the right end. The individual is asked to mark the point on this horizontal line that best expresses the severity of pain in his body. The distance from the point marked by the individual to the left end is measured and the pain score is determined. It is evaluated that the severity of the pain increases as the VAS value approaches 10, and decreases as it approaches 0. The lowest 0 and the highest 10 points are taken from the scale.
Visual Similarity Scale for Fatigue (YSSF)
Time frame: Change from Visual Similarity Scale for Fatigue (YSSF) scores at first, second, third, fourth, fifth, sixth, seventh and eighth week after cesarean. ]
It is in the form of a 10 cm ruler with the most positive statements on one end of the scale and the most negative statements on the other. The most positive expression of the fatigue sub-dimension is 0, the most negative expression is 10, the most negative expression of the energy sub-dimension is 0, and the most positive expression is 10. A high score of the fatigue sub-dimension and a low score of the energy sub-dimension indicate a high severity of fatigue. The calculation method of the scale is determined by adding up all the scores obtained from the scale items. The lowest score for YSSF is 0, and the highest score is 180. The lowest score for the YSSF fatigue sub-dimension is 0, and the highest score is 130. The lowest score is 0 for the energy sub-dimension of YSSF and the highest score is 50. The scale does not have a cut-off point.
Pittsburg Sleep Quality Index (PSQI)
Time frame: Change from Pittsburg Sleep Quality Index (PSQI) scores at first, fourth and eighth week after cesarean. ]
In order to evaluate the sleep quality in the last month, Buysse et al. (1989) is a quantitative measure of sleep quality as good and bad sleep. Its Turkish adaptation was done by Ağargün et al. (1996), Cronbach's α internal consistency coefficient is 0.80. It consists of a total of 24 questions and 7 sub-components. 18 items and 7 sub-components are included in the scoring. Each item is evaluated as 0-3 points and the sum of 7 sub-components forms the PSQI score. The lowest score of the scale is 0 and the highest score is 21. A total PSQI score of ≤5 indicates good sleep, and >5 indicates poor sleep.
Bristol Breastfeeding Assessment Tool (BBAT)
Time frame: Change from Bristol Breastfeeding Assessment Tool (BBAT) scores at first, second, third, fourth, fifth, sixth, seventh and eighth week after cesarean. ]
Each item in the scoring of the scale is between 0-2 points. The calculation method is the sum of all scores obtained from the scale items. The lowest score obtained from the scale is 0, and the highest score is 8. The scale does not have a breakpoint. A low score indicates that breastfeeding is ineffective, and a high score indicates that breastfeeding is effective.
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 14 Jun 2021.
- Individual participant dataSharing planned: No
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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.
simge zeyneloğlu, proffessor study director
GAZİANTEP UNİVERSİTY CLINICAL RESEARCH ETHICS COMMITTE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing foot reflexology in people with Breast Feeding and Fatigue, run by University of Gaziantep at 1 site in Turkey (Türkiye).
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 11 inclusion and 3 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 14 Jun 2021. 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 Turkey (Türkiye). 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?
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?
Visual Analogue Scale (VAS) (time frame: Change from Visual Analogue Scale (VAS) scores at first, second, third, fourth, fifth, sixth, seventh and eighth week after cesarean. ]). The study lists 4 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 14 Jun 2021.