- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04556643
Effectiveness of Breathing Exercises During the Second Stage of Labor
Effectiveness of Breathing Exercises During the Second Stage of Labor on Labor Pain and Duration
Study Overview
Detailed Description
This study is about to determine effectiveness of breathing exercises for pregnant women during the second stage of labor on maternal pain, duration of labor, dyspnea, oxygen saturation SPO2 and the first-minute Appearance, Pulse, Grimace, Activity and Respiration (APGAR) scores.
Two sessions will be given to pregnant women in Intervention group. One session breathing exercises training will be given during first stage of labor by the investigator. During training all participants in Intervention group will be instructed to perform breathing exercises during the second stage of labor. The main components of breathing exercises during training will be as fellows (A) First, fill your stomach and then your lungs with air while breathing in; (B) Feel the expansion in the stomach; (C) Make sure the muscles from your stomach to your knee are relaxed, as if you are urinating while breathing out; (D) When there is pain, perform deep abdominal breathing exercises, and take a deep breath in and hold as much as you can; (E) Try to push the baby downward; (F) You can do it by holding your breath or breathing out quite slowly from your mouth; (G) The most important point in this stage is that you should not fill up the stomach with air, and you should push downward to deliver the baby; (H) You should continue the pushing until the pain is relieved. The participants will be observed during second stage of labor and their breathing will be monitored.
- During the second stage of labor maternal labor pain will be assessed by Visual Analogue Scale.
- Duration of second stage of labor will be counted by turning on the stop watch on the start of second stage and it will be stopped at the end when baby will be delivered.
- Dyspnea will be monitored by dyspnea scale after performing breathing exercises during second stage of labor.
- Oxygen saturation will be monitored by pulse oximeter during second stage of labor.
- APGAR score of newborn will be marked in 1st minute after the birth.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kashmir
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Mirpur, Kashmir, Pakistan, 10250
- District headquarter hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pregnant females
- Gestational age ranging between 37 and 42 weeks
Exclusion Criteria:
Women using analgesics or anesthetics, Women with clinical instability Women with psychiatric disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention Group
Two sessions will be given to pregnant women in Intervention group.
One session breathing exercises training will be given during first stage of labor by the investigator.
During training all participants in Intervention group will be instructed to perform breathing exercises during the second stage of labor.
|
The main components of breathing exercises during training will be as follows (A) First, fill your stomach and then your lungs with air while breathing in; (B) Feel the expansion in the stomach; (C) Make sure the muscles from your stomach to your knee are relaxed, as if you are urinating while breathing out; (D) When there is pain, perform deep abdominal breathing exercises, and take a deep breath in and hold as much as you can; (E) Try to push the baby downward; (F) You can do it by holding your breath or breathing out quite slowly from your mouth; (G) The most important point in this stage is that you should not fill up the stomach with air, and you should push downward to deliver the baby; (H) You should continue the pushing until the pain is relieved
|
NO_INTERVENTION: Control Group
Usual hospital delivery protocol will be followed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog scale
Time Frame: 1 day (First Visit)
|
Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.
It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.
|
1 day (First Visit)
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Stop watch
Time Frame: 1 day (First Visit)
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A stopwatch is a handheld timepiece designed to measure the amount of time that elapses between its activation and deactivation.
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1 day (First Visit)
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DYSPNEA SCALE
Time Frame: 1 day (First Visit)
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Dyspnea Scale quantifies disability attributable to breathlessness, and is useful for characterizing baseline dyspnea in patients with respiratory diseases.
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1 day (First Visit)
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PULSE OXIMETER
Time Frame: 1 day (First Visit)
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Pulse oximeter is a noninvasive instrument for monitoring a person's oxygen saturation.
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1 day (First Visit)
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APGAR
Time Frame: 1 day (First Visit)
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Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration."
In the test, five things are used to check a baby's health.
Each is scored on a scale of 0 to 2, with 2 being the best score
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1 day (First Visit)
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Marshall NE, Fu R, Guise JM. Impact of multiple cesarean deliveries on maternal morbidity: a systematic review. Am J Obstet Gynecol. 2011 Sep;205(3):262.e1-8. doi: 10.1016/j.ajog.2011.06.035. Epub 2011 Jun 15.
- Lowe NK. The nature of labor pain. Am J Obstet Gynecol. 2002 May;186(5 Suppl Nature):S16-24. doi: 10.1067/mob.2002.121427.
- Cicek S, Basar F. The effects of breathing techniques training on the duration of labor and anxiety levels of pregnant women. Complement Ther Clin Pract. 2017 Nov;29:213-219. doi: 10.1016/j.ctcp.2017.10.006. Epub 2017 Oct 18.
- Amiri P, Mirghafourvand M, Esmaeilpour K, Kamalifard M, Ivanbagha R. The effect of distraction techniques on pain and stress during labor: a randomized controlled clinical trial. BMC Pregnancy Childbirth. 2019 Dec 30;19(1):534. doi: 10.1186/s12884-019-2683-y.
- Davim RM, Torres Gde V, Melo ES. Non-pharmacological strategies on pain relief during labor: pre-testing of an instrument. Rev Lat Am Enfermagem. 2007 Nov-Dec;15(6):1150-6. doi: 10.1590/s0104-11692007000600015.
- Lindholm A, Hildingsson I. Women's preferences and received pain relief in childbirth - A prospective longitudinal study in a northern region of Sweden. Sex Reprod Healthc. 2015 Jun;6(2):74-81. doi: 10.1016/j.srhc.2014.10.001. Epub 2014 Oct 12.
- Akarsu RH, Mucuk S. Turkish women's opinions about cesarean delivery. Pak J Med Sci. 2014 Nov-Dec;30(6):1308-13. doi: 10.12669/pjms.306.5748.
- Gonen R, Tamir A, Degani S. Obstetricians' opinions regarding patient choice in cesarean delivery. Obstet Gynecol. 2002 Apr;99(4):577-80. doi: 10.1016/s0029-7844(01)01766-5.
- Boaviagem A, Melo Junior E, Lubambo L, Sousa P, Aragao C, Albuquerque S, Lemos A. The effectiveness of breathing patterns to control maternal anxiety during the first period of labor: A randomized controlled clinical trial. Complement Ther Clin Pract. 2017 Feb;26:30-35. doi: 10.1016/j.ctcp.2016.11.004. Epub 2016 Nov 11.
- Yildirim G, Sahin NH. The effect of breathing and skin stimulation techniques on labour pain perception of Turkish women. Pain Res Manag. 2004 Winter;9(4):183-7. doi: 10.1155/2004/686913.
- Tranquilli AL, Biagini A, Greco P, Di Tommaso M, Giannubilo SR. The correlation between fetal bradycardia area in the second stage of labor and acidemia at birth. J Matern Fetal Neonatal Med. 2013 Sep;26(14):1425-9. doi: 10.3109/14767058.2013.784263. Epub 2013 Apr 17.
- Schiano MA, Hauth JC, Gilstrap LC 3rd. Second-stage fetal tachycardia and neonatal infection. Am J Obstet Gynecol. 1984 Mar 15;148(6):779-81. doi: 10.1016/0002-9378(84)90566-0.
- McNamara H, Johnson N. The effect of uterine contractions on fetal oxygen saturation. Br J Obstet Gynaecol. 1995 Aug;102(8):644-7. doi: 10.1111/j.1471-0528.1995.tb11403.x.
- Edelstone DI, Peticca BB, Goldblum LJ. Effects of maternal oxygen administration on fetal oxygenation during reductions in umbilical blood flow in fetal lambs. Am J Obstet Gynecol. 1985 Jun 1;152(3):351-8. doi: 10.1016/s0002-9378(85)80226-x.
- Davim RM, Torres Gde V, Dantas Jda C. [Effectiveness of non-pharmacological strategies in relieving labor pain]. Rev Esc Enferm USP. 2009 Jun;43(2):438-45. doi: 10.1590/s0080-62342009000200025. Portuguese.
- Milne JA, Howie AD, Pack AI. Dyspnoea during normal pregnancy. Br J Obstet Gynaecol. 1978 Apr;85(4):260-3. doi: 10.1111/j.1471-0528.1978.tb10497.x.
- Bernardi L, Spadacini G, Bellwon J, Hajric R, Roskamm H, Frey AW. Effect of breathing rate on oxygen saturation and exercise performance in chronic heart failure. Lancet. 1998 May 2;351(9112):1308-11. doi: 10.1016/S0140-6736(97)10341-5.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/00239 Maryam Waheed
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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