NCT04556643

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2020

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
Last Updated

September 21, 2020

Status Verified

September 1, 2020

Enrollment Period

7 months

First QC Date

September 16, 2020

Last Update Submit

September 18, 2020

Conditions

Keywords

labor painBreathing Exercisessecond stage of labor

Outcome Measures

Primary Outcomes (5)

  • Visual Analog scale

    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)

  • Stop watch

    A stopwatch is a handheld timepiece designed to measure the amount of time that elapses between its activation and deactivation.

    1 day (First Visit)

  • DYSPNEA SCALE

    Dyspnea Scale quantifies disability attributable to breathlessness, and is useful for characterizing baseline dyspnea in patients with respiratory diseases.

    1 day (First Visit)

  • PULSE OXIMETER

    Pulse oximeter is a noninvasive instrument for monitoring a person's oxygen saturation.

    1 day (First Visit)

  • APGAR

    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

    1 day (First Visit)

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Other: Breathing exercises

Control Group

NO INTERVENTION

Usual hospital delivery protocol will be followed.

Interventions

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

Intervention Group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant females
  • Gestational age ranging between 37 and 42 weeks

You may not qualify if:

  • Women using analgesics or anesthetics, Women with clinical instability Women with psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

District headquarter hospital

Mirpur, Kashmir, 10250, Pakistan

Location

Related Publications (17)

  • 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.

    PMID: 29122264BACKGROUND
  • 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.

    PMID: 31888543BACKGROUND
  • 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.

    PMID: 18235958BACKGROUND
  • 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.

    PMID: 25998874BACKGROUND
  • 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.

    PMID: 22071057BACKGROUND
  • 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.

    PMID: 25674129BACKGROUND
  • 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.

    PMID: 12039114BACKGROUND
  • 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.

    PMID: 12011870BACKGROUND
  • 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.

    PMID: 28107846BACKGROUND
  • 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.

    PMID: 15605131BACKGROUND
  • 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.

    PMID: 23488805BACKGROUND
  • 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.

    PMID: 6702948BACKGROUND
  • 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.

    PMID: 7654643BACKGROUND
  • 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.

    PMID: 4003479BACKGROUND
  • 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.

    PMID: 19655687BACKGROUND
  • 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.

    PMID: 638094BACKGROUND
  • 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.

    PMID: 9643792BACKGROUND

MeSH Terms

Conditions

Labor Pain

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Anam Aftab, Phd*

    Riphah college of rehabilitation and allied health sciences - Rawalpindi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2020

First Posted

September 21, 2020

Study Start

January 15, 2020

Primary Completion

August 15, 2020

Study Completion

September 1, 2020

Last Updated

September 21, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations