Clinical trial NCT04037202: Effect of Foot Massage on Postpartum Comfort and Pain Level of the Mothers Who Had Vaginal Birth
Official title: Effect of Foot Massage on Postpartum Comfort and Pain Level of the Mothers Who Had Vaginal Birth: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Disorder
Massage
Keywords: analgesia
massage
midwifery
pain
postpartum period
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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,
* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Informed Consent Form
timeFrame: 5-10 minutes
measure: Postpartum Comfort Scale (PCS)
timeFrame: 5-10 minutes
measure: Visual Analog Scale (VAS)
timeFrame: Less than 1 minute
measure: Drug Follow-up Card (DFC)
timeFrame: About 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University
state: Bornova
Study officials:
References:
citation: 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.
citation: Abbaspoor 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.
citation: Saatsaz 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.
citation: Asazawa 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.
citation: Xue 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.
citation: Degirmen 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.
citation: Eogan 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.
citation: Wang 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.
citation: Coban 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.
citation: Santos 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.
citation: Aksoy 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.
citation: Senol 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.
citation: Moghimi-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.
citation: Jahdi 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.
citation: Adib-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.
citation: Can HO, Saruhan A. Evaluation of the effects of ice massage applied to large intestine 4 (hegu) on postpartum pain during the active phase of labor. Iran J Nurs Midwifery Res. 2015 Jan-Feb;20(1):129-38.
citation: Hattan J, King L, Griffiths P. The impact of foot massage and guided relaxation following cardiac surgery: a randomized controlled trial. J Adv Nurs. 2002 Jan;37(2):199-207. doi: 10.1046/j.1365-2648.2002.02083.x.
citation: Deussen AR, Ashwood P, Martis R, Stewart F, Grzeskowiak LE. Relief of pain due to uterine cramping/involution after birth. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD004908. doi: 10.1002/14651858.CD004908.pub3.