Labor PainNCT04556643
Effectiveness of Breathing Exercises During the Second Stage of Labor
A study testing Breathing exercises in people with Labor Pain, run by Riphah International University at 1 site in Pakistan.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- Breathing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2020to 1 Sep 2020
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant females
- Gestational age ranging between 37 and 42 weeks
Who cannot join
- Women using analgesics or anesthetics, Women with clinical instability Women with psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Breathing Exercises During the Second Stage of Labor on Labor Pain and Duration
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
Read the 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.
- Conditions
- Labor Pain
- Being tested
- Breathing exercises
- Keywords
- labor pain, Breathing Exercises, second stage of labor
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing exercisesOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Breathing exercises |
| Control Group | No intervention | Usual hospital delivery protocol will be followed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 day (First Visit)
PULSE OXIMETER
Pulse oximeter is a noninvasive instrument for monitoring a person's oxygen saturation.
Measured: 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
Measured: 1 day (First Visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start15 Jan 2020
- Primary completion15 Aug 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anam Aftab, Phd*, Principal investigator, Riphah college of rehabilitation and allied health sciences - Rawalpindi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556643
- Sponsor's protocol ID
- REC/00239 Maryam Waheed
- Status last verified
- Sep 2020
- First submitted
- 16 Sep 2020
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29122264Amiri 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.
PubMed 31888543Davim 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.
PubMed 18235958Lindholm 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.
PubMed 25998874Marshall 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.
PubMed 22071057Akarsu 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.
PubMed 25674129Gonen 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.
PubMed 12039114Lowe NK. The nature of labor pain. Am J Obstet Gynecol. 2002 May;186(5 Suppl Nature):S16-24. doi: 10.1067/mob.2002.121427.
PubMed 12011870Boaviagem 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.
PubMed 28107846Yildirim 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.
PubMed 15605131Tranquilli 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.
PubMed 23488805Schiano 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.
PubMed 6702948McNamara 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.
PubMed 7654643Edelstone 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.
PubMed 4003479Davim 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.
PubMed 19655687
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Breathing Exercises During the Second Stage of Labor on Labor Pain and Duration
- ClinicalTrials.gov ID
- NCT04556643
- Acronym / sponsor ID
- REC/00239 Maryam Waheed
- Conditions
- Labor Pain
- Keywords
- labor pain, Breathing Exercises, second stage of labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 21 Sep 2020 (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.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Breathing exercisesTwo 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. |
| Control Group | No intervention | –Usual hospital delivery protocol will be followed. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant females
- Gestational age ranging between 37 and 42 weeks
Key exclusion criteria (1 listed)
- Women using analgesics or anesthetics, Women with clinical instability Women with psychiatric disorders
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 |
|---|---|---|
| Breathing exercisesThe 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 | Other | Intervention Group |
Primary outcome
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.
Stop watch
Time frame: 1 day (First Visit)
A stopwatch is a handheld timepiece designed to measure the amount of time that elapses between its activation and deactivation.
DYSPNEA SCALE
Time frame: 1 day (First Visit)
Dyspnea Scale quantifies disability attributable to breathlessness, and is useful for characterizing baseline dyspnea in patients with respiratory diseases.
PULSE OXIMETER
Time frame: 1 day (First Visit)
Pulse oximeter is a noninvasive instrument for monitoring a person's oxygen saturation.
APGAR
Time frame: 1 day (First Visit)
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
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 21 Sep 2020.
- Background: PubMed 29122264Cicek 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.
- Background: PubMed 31888543Amiri 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.
- Background: PubMed 18235958Davim 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.
- Background: PubMed 25998874Lindholm 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.
- Background: PubMed 22071057Marshall 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.
- Background: PubMed 25674129Akarsu 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.
- Background: PubMed 12039114Gonen 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.
- Background: PubMed 12011870Lowe NK. The nature of labor pain. Am J Obstet Gynecol. 2002 May;186(5 Suppl Nature):S16-24. doi: 10.1067/mob.2002.121427.
- Background: PubMed 28107846Boaviagem 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.
- Background: PubMed 15605131Yildirim 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.
- Background: PubMed 23488805Tranquilli 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.
- Background: PubMed 6702948Schiano 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.
- 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.
Anam Aftab, Phd* principal investigator
Riphah college of rehabilitation and allied health sciences - Rawalpindi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing exercises in people with Labor Pain, run by Riphah International University at 1 site in Pakistan.
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 2 inclusion and 1 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 21 Sep 2020. 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 Pakistan. 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 Analog scale (time frame: 1 day (First Visit)). The study lists 5 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 NCT04556643, which also lists 17 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 21 Sep 2020.