Effectiveness of Breathing Exercises During the Second Stage of Labor
Primary Purpose
Labor Pain
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Breathing exercises
Sponsored by
About this trial
This is an interventional treatment trial for Labor Pain focused on measuring labor pain, Breathing Exercises, second stage of labor
Eligibility Criteria
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
Sites / Locations
- District headquarter hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Control Group
Arm Description
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.
Usual hospital delivery protocol will be followed.
Outcomes
Primary Outcome Measures
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.
Stop watch
A stopwatch is a handheld timepiece designed to measure the amount of time that elapses between its activation and deactivation.
DYSPNEA SCALE
Dyspnea Scale quantifies disability attributable to breathlessness, and is useful for characterizing baseline dyspnea in patients with respiratory diseases.
PULSE OXIMETER
Pulse oximeter is a noninvasive instrument for monitoring a person's oxygen saturation.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04556643
First Posted
September 16, 2020
Last Updated
September 18, 2020
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT04556643
Brief Title
Effectiveness of Breathing Exercises During the Second Stage of Labor
Official Title
Effectiveness of Breathing Exercises During the Second Stage of Labor on Labor Pain and Duration
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
August 15, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
labor pain, Breathing Exercises, second stage of labor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
264 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Usual hospital delivery protocol will be followed.
Intervention Type
Other
Intervention Name(s)
Breathing exercises
Intervention Description
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
Primary Outcome Measure Information:
Title
Visual Analog scale
Description
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.
Time Frame
1 day (First Visit)
Title
Stop watch
Description
A stopwatch is a handheld timepiece designed to measure the amount of time that elapses between its activation and deactivation.
Time Frame
1 day (First Visit)
Title
DYSPNEA SCALE
Description
Dyspnea Scale quantifies disability attributable to breathlessness, and is useful for characterizing baseline dyspnea in patients with respiratory diseases.
Time Frame
1 day (First Visit)
Title
PULSE OXIMETER
Description
Pulse oximeter is a noninvasive instrument for monitoring a person's oxygen saturation.
Time Frame
1 day (First Visit)
Title
APGAR
Description
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
Time Frame
1 day (First Visit)
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anam Aftab, Phd*
Organizational Affiliation
Riphah college of rehabilitation and allied health sciences - Rawalpindi
Official's Role
Principal Investigator
Facility Information:
Facility Name
District headquarter hospital
City
Mirpur
State/Province
Kashmir
ZIP/Postal Code
10250
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of Breathing Exercises During the Second Stage of Labor
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