Postpartum DisorderNCT04037202
Effect of Foot Massage on Postpartum Comfort and Pain Level of the Mothers Who Had Vaginal Birth
A study testing Foot massage in people with Postpartum Disorder and Massage, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Background and Purpose: This study aims to investigate the effect of foot massage in the postpartum period on the need of receiving analgesic medication after assessing the postpartum comfort and pain status of the mothers who had vaginal delivery.Materials and methods: The study was completed with 66 mothers. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Disorder, Massage
- What is being tested?
- Foot massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jul 2017to 1 Sep 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- primipara mothers (who had their first birth),
- mothers who had normal vaginal delivery,
- those who had undergone episiotomy,
- who were volunteered to participate in the study,
- who were on the first day of delivery (first 24 hours),
- who had no complications in the infant and the baby,
Show all 10Show fewer
- age of whom ranged from 18 to 35,
- those who did not apply or receive any other complementary therapy,
- mothers who did not have any wound, infection or discomfort etc. on their feet,
- mothers who can read and write
Who cannot join
- mothers with any systemic disease
- mothers who dislike foot massage during practice
- early discharge mothers
- mothers who applied another massage technique
- mothers who take the analgesic drug unnecessarily
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Foot Massage on Postpartum Comfort and Pain Level of the Mothers Who Had Vaginal Birth: A Randomised Controlled Trial
Background and Purpose: This study aims to investigate the effect of foot massage in the postpartum period on the need of receiving analgesic medication after assessing the postpartum comfort and pain status of the mothers who had vaginal delivery.Materials and methods: The study was completed with 66 mothers. As data collection tools, a questionnaire, Postpartum Comfort Scale (PCS), Visual Analogue Scale (VAS) and Drug Follow-up Card (DFC) were used.
Read the detailed description
Background and purpose: This study aims to investigate the effect of foot massage in the postpartum period on the need of receiving analgesic medication after assessing the postpartum comfort and pain status of the mothers who had vaginal delivery.
Materials and methods: In order to keep the number of people in balance between the groups, "block randomization" method which is one of the fixed probability randomization types was preferred. The research was completed with 66 persons, 33 in the study group and 33 in the control group. As data collection tools, a questionnaire, Postpartum Comfort Scale (PCS), Visual Analogue Scale (VAS) and Drug Follow-up Card (DFC) were used.
Research inclusion criteria include (i) primipara mothers (who had their first birth), (ii) mothers who had normal vaginal delivery, (iii) those who had undergone episiotomy, (iv) who were volunteered to participate in the study, (v) who were on the first day of delivery (first 24 hours), (vi) who had no complications in the infant and the baby, (vii) age of whom ranged from 18 to 35, (viii) those who did not apply or receive any other complementary therapy, (ix) mothers who did not have any wound, infection or discomfort etc. on their feet, and those who can read and write.
- Conditions
- Postpartum Disorder, Massage
- Being tested
- Foot massage
- Keywords
- analgesia, massage, midwifery, pain, postpartum period
- Medical subject headings
- Puerperal Disorders, Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot massageOther
Foot massage includes classical massage techniques such as effleurage, petrissage and friction techniques. Effleurage is the movement of stroking and lubricating superficial tissues. Therefore, it is performed at the beginning and ending of the massage. Petrissage is the slow and rhythmic movement to apply direct pressure to the soft tissue underlying the skin with the balls of the fingers and thumbs. Friction is the application of pressure through small circular movements only in small areas, using hand or fingers. While muscle tissue is compressed and relaxed, blood and lymph circulation increases. Thus, lactic acid in the muscle fibers is diminished and fatigue and stress are decreased.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | The first session of the foot massage was performed after mothers were taken to the postpartum service and after the effect of the first analgesia had elapsed (4-6 hours after birth).
The researcher prepared the mother for foot massage (foot care, proper position, etc.) and gave a total of 20-minute massage of foot massage, 10 minutes for each foot. VAS was repeated immediately after the first session (in the 20th minute) and after 30 minutes (in the 50th minute). The second session was performed on the second day, 20-24 hours after the first session (before the discharge). The VAS was analyzed before the second (last) session (0th minute), and the VAS was repeated immediately after the application (20th minute) and 30 minutes (50th minute), and the PCS was administered for the last time. Administered analgesics were recorded in the DFC and the administration made with package leaflet was supported. Receives: Other: Foot massage |
| Control Group | No intervention | Routine procedures were applied and VAS was repeated at the same time periodical as the study group mothers (0th, 20th and 50th minute) and after 20-24 hours (before discharge), at the same time intervals (0th, 20th and 50th minute) pain status was measured by using VAS and PCS was administered for the last time and analgesics administered were recorded on the DFC. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Informed Consent Form
The form consists of 31 questions about family, pregnancy, birth and newborn characteristics.This form was completed during the first meeting at the hospital.
Measured: 5-10 minutes
Postpartum Comfort Scale (PCS)
In accordance with the comfort theory developed by Katharine Kolcaba in 1994, the PCS developed by Karakaplan and Yıldız (2010) consists of 34 items.A 5-point Likert-type scoring system was used to evaluate each item.Expression and scoring were made for each item ranging from "totally agree" (5 points), and "strongly disagree" (1 points).In positive sentences, "I fully agree" indicates the best comfort (5 points) and in negative sentences low comfort (1 points).Accordingly, the lowest score to be taken from the scale is 34 and the highest score is 170.
Measured: 5-10 minutes
Visual Analog Scale (VAS)
It is a single-item continuous scale consisting of a horizontal or vertical line and is usually 10 centimeters (100 mm) in length. For example, the severity of pain a patient feels ranges from "no pain" with 0 points on a line to "severe pain" with 10 points.Scoring is achieved by measuring the point the patient has marked with a ruler.Pain relief points in VAS;
- Absence of pain (0-4 mm),
- Slight pain (5-44 mm),
- Moderate pain (45-74 mm)
- Severe pain (75-100 mm)
Measured: Less than 1 minute
Drug Follow-up Card (DFC)
The researcher was prepared, this is a follow-up card in which the name and surname of the mothers, the name of the drug given to the mothers, the route of administration of the drug, date / time and dosage are indicated.
Measured: About 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start3 Jul 2017
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Postpartum DisorderStudies of the same condition, open and under way.
- More trials run by Ege 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
- Model description
- The researcher prepared the mother for foot massage (foot care, proper position, etc.) and gave a total of 20-minute massage of foot massage, 10 minutes for each foot. VAS was repeated immediately after the first session (in the 20th minute) and after 30 minutes (in the 50th minute). The second session was performed on the second day, 20-24 hours after the first session (before the discharge). The VAS was analyzed before the second (last) session (0th minute), and the VAS was repeated immediately after the application (20th minute) and 30 minutes (50th minute), and the PCS was administered for the last time. Administered analgesics were recorded in the DFC and the administration made with package leaflet was supported.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabia Genç, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037202
- Sponsor's protocol ID
- 0000-0002-6762-0496
- Status last verified
- Jul 2019
- First submitted
- 24 Jul 2019
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Simavli S, Kaygusuz I, Gumus I, Usluogullari B, Yildirim M, Kafali H. Effect of music therapy during vaginal delivery on postpartum pain relief and mental health. J Affect Disord. 2014 Mar;156:194-9. doi: 10.1016/j.jad.2013.12.027. Epub 2013 Dec 28.
PubMed 24411681Abbaspoor Z, Akbari M, Najar S. Effect of foot and hand massage in post-cesarean section pain control: a randomized control trial. Pain Manag Nurs. 2014 Mar;15(1):132-6. doi: 10.1016/j.pmn.2012.07.008. Epub 2013 Jan 24.
PubMed 23352729Saatsaz S, Rezaei R, Alipour A, Beheshti Z. Massage as adjuvant therapy in the management of post-cesarean pain and anxiety: A randomized clinical trial. Complement Ther Clin Pract. 2016 Aug;24:92-8. doi: 10.1016/j.ctcp.2016.05.014. Epub 2016 May 30.
PubMed 27502807Asazawa K PhD, Kato Y Bs, Yamaguchi A Ms, Inoue A Bs. The Effect of Aromatherapy Treatment on Fatigue and Relaxation for Mothers during the Early Puerperal Period in Japan: A Pilot Study. Int J Community Based Nurs Midwifery. 2017 Oct;5(4):365-375.
PubMed 29043282Xue M, Fan L, Ge LN, Zhang Y, Ge JL, Gu J, Wang Y, Chen Y. Postoperative Foot Massage for Patients after Caesarean Delivery. Z Geburtshilfe Neonatol. 2016 Aug;220(4):173-8. doi: 10.1055/s-0042-104802. Epub 2016 Aug 10.
PubMed 27509141Degirmen N, Ozerdogan N, Sayiner D, Kosgeroglu N, Ayranci U. Effectiveness of foot and hand massage in postcesarean pain control in a group of Turkish pregnant women. Appl Nurs Res. 2010 Aug;23(3):153-8. doi: 10.1016/j.apnr.2008.08.001. Epub 2009 Jan 15.
PubMed 20643325Eogan M, Daly L, O'Herlihy C. The effect of regular antenatal perineal massage on postnatal pain and anal sphincter injury: a prospective observational study. J Matern Fetal Neonatal Med. 2006 Apr;19(4):225-9. doi: 10.1080/14767050600593155.
PubMed 16854696Wang HL, Keck JF. Foot and hand massage as an intervention for postoperative pain. Pain Manag Nurs. 2004 Jun;5(2):59-65. doi: 10.1016/j.pmn.2004.01.002.
PubMed 15297952Coban A, Sirin A. Effect of foot massage to decrease physiological lower leg oedema in late pregnancy: a randomized controlled trial in Turkey. Int J Nurs Pract. 2010 Oct;16(5):454-60. doi: 10.1111/j.1440-172X.2010.01869.x.
PubMed 20854342Santos Jde O, Oliveira SM, Nobre MR, Aranha AC, Alvarenga MB. A randomised clinical trial of the effect of low-level laser therapy for perineal pain and healing after episiotomy: a pilot study. Midwifery. 2012 Oct;28(5):e653-9. doi: 10.1016/j.midw.2011.07.009. Epub 2011 Oct 5.
PubMed 21982202Aksoy Derya Y, Pasinlioglu T. The Effect of Nursing Care Based on Comfort Theory on Women's Postpartum Comfort Levels After Caesarean Sections. Int J Nurs Knowl. 2017 Jul;28(3):138-144. doi: 10.1111/2047-3095.12122. Epub 2015 Nov 25.
PubMed 26602188Senol DK, Aslan E. The Effects of Cold Application to the Perineum on Pain Relief After Vaginal Birth. Asian Nurs Res (Korean Soc Nurs Sci). 2017 Dec;11(4):276-282. doi: 10.1016/j.anr.2017.11.001. Epub 2017 Nov 26.
PubMed 29290275Moghimi-Hanjani S, Mehdizadeh-Tourzani Z, Shoghi M. The Effect of Foot Reflexology on Anxiety, Pain, and Outcomes of the Labor in Primigravida Women. Acta Med Iran. 2015 Aug;53(8):507-11.
PubMed 26545996Jahdi F, Mehrabadi M, Mortazavi F, Haghani H. The Effect of Slow-Stroke Back Massage on the Anxiety Levels of Iranian Women on the First Postpartum Day. Iran Red Crescent Med J. 2016 Jun 7;18(8):e34270. doi: 10.5812/ircmj.34270. eCollection 2016 Aug.
PubMed 27781122Adib-Hajbaghery M, Abasi A, Rajabi-Beheshtabad R. Whole body massage for reducing anxiety and stabilizing vital signs of patients in cardiac care unit. Med J Islam Repub Iran. 2014 Jun 17;28:47. eCollection 2014.
PubMed 25405113
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Foot Massage on Postpartum Comfort and Pain Level of the Mothers Who Had Vaginal Birth: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04037202
- Acronym / sponsor ID
- 0000-0002-6762-0496
- Conditions
- Postpartum Disorder, Massage
- Keywords
- analgesia, massage, midwifery, pain, postpartum period
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 3 Jul 2017 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 30 Jul 2019 (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.
Background and Purpose: This study aims to investigate the effect of foot massage in the postpartum period on the need of receiving analgesic medication after assessing the postpartum comfort and pain status of the mothers who had vaginal delivery.Materials and methods: The study was completed with 66 mothers. As data collection tools, a questionnaire, Postpartum Comfort Scale (PCS), Visual Analogue Scale (VAS) and Drug Follow-up Card (DFC) were used.
Detailed description
Background and purpose: This study aims to investigate the effect of foot massage in the postpartum period on the need of receiving analgesic medication after assessing the postpartum comfort and pain status of the mothers who had vaginal delivery.
Materials and methods: In order to keep the number of people in balance between the groups, "block randomization" method which is one of the fixed probability randomization types was preferred. The research was completed with 66 persons, 33 in the study group and 33 in the control group. As data collection tools, a questionnaire, Postpartum Comfort Scale (PCS), Visual Analogue Scale (VAS) and Drug Follow-up Card (DFC) were used.
Research inclusion criteria include (i) primipara mothers (who had their first birth), (ii) mothers who had normal vaginal delivery, (iii) those who had undergone episiotomy, (iv) who were volunteered to participate in the study, (v) who were on the first day of delivery (first 24 hours), (vi) who had no complications in the infant and the baby, (vii) age of whom ranged from 18 to 35, (viii) those who did not apply or receive any other complementary therapy, (ix) mothers who did not have any wound, infection or discomfort etc. on their feet, and those who can read and write.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The researcher prepared the mother for foot massage (foot care, proper position, etc.) and gave a total of 20-minute massage of foot massage, 10 minutes for each foot. VAS was repeated immediately after the first session (in the 20th minute) and after 30 minutes (in the 50th minute). The second session was performed on the second day, 20-24 hours after the first session (before the discharge). The VAS was analyzed before the second (last) session (0th minute), and the VAS was repeated immediately after the application (20th minute) and 30 minutes (50th minute), and the PCS was administered for the last time. Administered analgesics were recorded in the DFC and the administration made with package leaflet was supported.
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Foot massageThe first session of the foot massage was performed after mothers were taken to the postpartum service and after the effect of the first analgesia had elapsed (4-6 hours after birth). The researcher prepared the mother for foot massage (foot care, proper position, etc.) and gave a total of 20-minute massage of foot massage, 10 minutes for each foot. VAS was repeated immediately after the first session (in the 20th minute) and after 30 minutes (in the 50th minute). The second session was performed on the second day, 20-24 hours after the first session (before the discharge). The VAS was analyzed before the second (last) session (0th minute), and the VAS was repeated immediately after the application (20th minute) and 30 minutes (50th minute), and the PCS was administered for the last time. Administered analgesics were recorded in the DFC and the administration made with package leaflet was supported. |
| Control Group | No intervention | –Routine procedures were applied and VAS was repeated at the same time periodical as the study group mothers (0th, 20th and 50th minute) and after 20-24 hours (before discharge), at the same time intervals (0th, 20th and 50th minute) pain status was measured by using VAS and PCS was administered for the last time and analgesics administered were recorded on the DFC. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- primipara mothers (who had their first birth),
- mothers who had normal vaginal delivery,
- those who had undergone episiotomy,
- who were volunteered to participate in the study,
- who were on the first day of delivery (first 24 hours),
Key exclusion criteria (5 listed)
- mothers with any systemic disease
- mothers who dislike foot massage during practice
- early discharge mothers
- mothers who applied another massage technique
- mothers who take the analgesic drug unnecessarily
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 massageFoot massage includes classical massage techniques such as effleurage, petrissage and friction techniques. Effleurage is the movement of stroking and lubricating superficial tissues. Therefore, it is performed at the beginning and ending of the massage. Petrissage is the slow and rhythmic movement to apply direct pressure to the soft tissue underlying the skin with the balls of the fingers and thumbs. Friction is the application of pressure through small circular movements only in small areas, using hand or fingers. While muscle tissue is compressed and relaxed, blood and lymph circulation increases. Thus, lactic acid in the muscle fibers is diminished and fatigue and stress are decreased. | Other | Study Group |
Primary outcome
Informed Consent Form
Time frame: 5-10 minutes
The form consists of 31 questions about family, pregnancy, birth and newborn characteristics.This form was completed during the first meeting at the hospital.
Postpartum Comfort Scale (PCS)
Time frame: 5-10 minutes
In accordance with the comfort theory developed by Katharine Kolcaba in 1994, the PCS developed by Karakaplan and Yıldız (2010) consists of 34 items.A 5-point Likert-type scoring system was used to evaluate each item.Expression and scoring were made for each item ranging from "totally agree" (5 points), and "strongly disagree" (1 points).In positive sentences, "I fully agree" indicates the best comfort (5 points) and in negative sentences low comfort (1 points).Accordingly, the lowest score to be taken from the scale is 34 and the highest score is 170.
Visual Analog Scale (VAS)
Time frame: Less than 1 minute
It is a single-item continuous scale consisting of a horizontal or vertical line and is usually 10 centimeters (100 mm) in length. For example, the severity of pain a patient feels ranges from "no pain" with 0 points on a line to "severe pain" with 10 points.Scoring is achieved by measuring the point the patient has marked with a ruler.Pain relief points in VAS; * Absence of pain (0-4 mm), * Slight pain (5-44 mm), * Moderate pain (45-74 mm) * Severe pain (75-100 mm)
Drug Follow-up Card (DFC)
Time frame: About 1 minute
The researcher was prepared, this is a follow-up card in which the name and surname of the mothers, the name of the drug given to the mothers, the route of administration of the drug, date / time and dosage are indicated.
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 30 Jul 2019.
- Background: PubMed 24411681Simavli S, Kaygusuz I, Gumus I, Usluogullari B, Yildirim M, Kafali H. Effect of music therapy during vaginal delivery on postpartum pain relief and mental health. J Affect Disord. 2014 Mar;156:194-9. doi: 10.1016/j.jad.2013.12.027. Epub 2013 Dec 28.
- Background: PubMed 23352729Abbaspoor Z, Akbari M, Najar S. Effect of foot and hand massage in post-cesarean section pain control: a randomized control trial. Pain Manag Nurs. 2014 Mar;15(1):132-6. doi: 10.1016/j.pmn.2012.07.008. Epub 2013 Jan 24.
- Background: PubMed 27502807Saatsaz S, Rezaei R, Alipour A, Beheshti Z. Massage as adjuvant therapy in the management of post-cesarean pain and anxiety: A randomized clinical trial. Complement Ther Clin Pract. 2016 Aug;24:92-8. doi: 10.1016/j.ctcp.2016.05.014. Epub 2016 May 30.
- Background: PubMed 29043282Asazawa K PhD, Kato Y Bs, Yamaguchi A Ms, Inoue A Bs. The Effect of Aromatherapy Treatment on Fatigue and Relaxation for Mothers during the Early Puerperal Period in Japan: A Pilot Study. Int J Community Based Nurs Midwifery. 2017 Oct;5(4):365-375.
- Background: PubMed 27509141Xue M, Fan L, Ge LN, Zhang Y, Ge JL, Gu J, Wang Y, Chen Y. Postoperative Foot Massage for Patients after Caesarean Delivery. Z Geburtshilfe Neonatol. 2016 Aug;220(4):173-8. doi: 10.1055/s-0042-104802. Epub 2016 Aug 10.
- Background: PubMed 20643325Degirmen N, Ozerdogan N, Sayiner D, Kosgeroglu N, Ayranci U. Effectiveness of foot and hand massage in postcesarean pain control in a group of Turkish pregnant women. Appl Nurs Res. 2010 Aug;23(3):153-8. doi: 10.1016/j.apnr.2008.08.001. Epub 2009 Jan 15.
- Background: PubMed 16854696Eogan M, Daly L, O'Herlihy C. The effect of regular antenatal perineal massage on postnatal pain and anal sphincter injury: a prospective observational study. J Matern Fetal Neonatal Med. 2006 Apr;19(4):225-9. doi: 10.1080/14767050600593155.
- Background: PubMed 15297952Wang HL, Keck JF. Foot and hand massage as an intervention for postoperative pain. Pain Manag Nurs. 2004 Jun;5(2):59-65. doi: 10.1016/j.pmn.2004.01.002.
- Background: PubMed 20854342Coban A, Sirin A. Effect of foot massage to decrease physiological lower leg oedema in late pregnancy: a randomized controlled trial in Turkey. Int J Nurs Pract. 2010 Oct;16(5):454-60. doi: 10.1111/j.1440-172X.2010.01869.x.
- Background: PubMed 21982202Santos Jde O, Oliveira SM, Nobre MR, Aranha AC, Alvarenga MB. A randomised clinical trial of the effect of low-level laser therapy for perineal pain and healing after episiotomy: a pilot study. Midwifery. 2012 Oct;28(5):e653-9. doi: 10.1016/j.midw.2011.07.009. Epub 2011 Oct 5.
- Background: PubMed 26602188Aksoy Derya Y, Pasinlioglu T. The Effect of Nursing Care Based on Comfort Theory on Women's Postpartum Comfort Levels After Caesarean Sections. Int J Nurs Knowl. 2017 Jul;28(3):138-144. doi: 10.1111/2047-3095.12122. Epub 2015 Nov 25.
- Background: PubMed 29290275Senol DK, Aslan E. The Effects of Cold Application to the Perineum on Pain Relief After Vaginal Birth. Asian Nurs Res (Korean Soc Nurs Sci). 2017 Dec;11(4):276-282. doi: 10.1016/j.anr.2017.11.001. Epub 2017 Nov 26.
- Factors that affecting mothers' postnatal comfortLink provided by the sponsor.
- Effect of Uterine Massage in the Perception of Women's Postpartum Pain IntensityLink provided by the sponsor.
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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.
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 massage in people with Postpartum Disorder and Massage, run by Ege University 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 10 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: finished, as of the sponsor's last update on 30 Jul 2019. 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?
Informed Consent Form (time frame: 5-10 minutes). 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?
On the ClinicalTrials.gov record for NCT04037202, which also lists 18 linked publications.
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 Jul 2019.