Labor PainNCT04883047
The Effectiveness of the Applications Made in Line With the Algorithm for Coping With Labor Pain
A study testing holistic birth support strategies in people with Labor Pain, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Although labor pain is a physiological and natural process, when the woman cannot cope with labor pain, the health of the mother and fetus is negatively affected. These negative effects mostly focus on the respiratory system, cardiovascular system, neuroendocrine and limbic system. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- holistic birth support strategies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 May 2021to 25 Jun 2021
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being in the latent phase of labor
- Not being a risky pregnant (gestational diabetes, hypertension, preeclampsia etc.)
- Not having any communication problems (mental, auditory, visual, etc.)
Who cannot join
- Pregnancy does not do the post-test applications
- Not wanting to participate in interventions applied in line with the algorithm for coping with labor pain
- Willing to leave the research
- Delivery by cesarean section
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karabük Training and Research Hospital
Karabük, 78050
About this study
Official title: Evaluation of the Effects of Practices Performed in Accordance With the Algorithm of Coping With Birth Pain on Coping With Birth Pain, Birth Satisfaction and Birth Fear: A Randomized Controlled Study
Although labor pain is a physiological and natural process, when the woman cannot cope with labor pain, the health of the mother and fetus is negatively affected. These negative effects mostly focus on the respiratory system, cardiovascular system, neuroendocrine and limbic system. During birth, the mother becomes exhausted due to pain and has to use all her energy to cope with the pain.When the mother can effectively cope with the pain of labor, she starts motherhood with a positive experience, experiences the happiness of actively participating in the birth of the baby, can participate in practices with health professionals, and the problems that can be seen in the newborn are reduced because there is no need for medication. In this respect, it is extremely important for the mother, baby and family to end the birth process in the best possible way. For this reason, nursing care includes emotional, physical, spiritual and psychosocial continuous birth support and coping with the pain of labor. In this direction, the "algorithm for coping with labor pain" developed includes the interventions that should be done to cope with the pain in labor.
Read the detailed description
Pain is defined as an unpleasant emotional sensation originating from a certain part of the body, often related to tissue damage, and related to the past experiences of the person. Labor pain is an experience that is a part of a natural process, takes place in a limited time, and is perceived and experienced differently by every woman. Physiological changes during labor such as maternal age, parity, weight of mother and baby, position of the fetus, anatomical structure of the pelvis, cervical dilatation and uterine contractions; psychological factors such as perception of threats to the body or soul, culture, ethnicity, anxiety, loneliness, loss of control, fear that a painful or painful event will occur, anxiety that the baby or himself may be harmed, previous pain experiences and healthcare professionals' communication with the pregnant woman Environmental factors such as noise, lighting, and birth pain significantly affect the pregnant woman's coping with labor pain.
Although labor pain is a physiological and natural process, when the woman cannot cope with labor pain, the health of the mother and fetus is adversely affected. These negative effects mostly focus on the respiratory system, cardiovascular system, neuroendocrine and limbic system. During birth, the mother becomes exhausted due to pain and has to use all her energy to cope with the pain. When the mother cannot cope, she becomes tired, and her oxygen requirement, blood pressure and cardiac out-put increase. Fear and anxiety caused by labor pain increase the release of stress hormones such as adrenaline, noradrenaline and corticosteroid. These hormones reduce the blood flow to the uterus and cause distress in the fetus by reducing the amount of oxygen in the placental flow. In addition, due to the increased adrenaline, it causes a decrease in the amount of oxytocin during delivery. This causes prolongation of labor and more bleeding. At the same time, when the woman is able to cope with labor pain, the formation of tetany in the pregnant woman is prevented by preventing hyper ventilation and hypocapnia formation.
When the mother can effectively cope with the pain of labor, she starts motherhood with a positive experience, experiences the happiness of actively participating in the birth of the baby, can participate in practices with health professionals, and the problems that may be seen in the newborn are reduced since there is no need for medication. In this respect, it is extremely important for the mother, baby and family to end the birth process in the best possible way. For this reason, nursing care includes emotional, physical, spiritual and psychosocial continuous birth support and coping with the pain of labor. Providing non-pharmacological pain relief methods such as relaxation and breathing exercises, massage, positioning, therapeutic communication, listening to music, hot-cold application, partner and family support, providing home environment is associated with a positive birth experience. Accordingly, the "algorithm for coping with labor pain" developed by Roberts et al. (2010) includes the interventions that should be done to cope with the pain at birth. The algorithm for coping with labor pain has two branches. One is the arm that shows pregnant ways of coping with pain, such as rhythmic activity, deep breathing, inner focus, relaxation between contractions, which gives clues to healthcare professionals; Another is the arm that enables the evaluation of the findings that show that the woman cannot cope with labor pain such as clenching her teeth, crying, and inability to focus. According to the algorithm, when a woman can cope with labor pain, there is no need to do any intervention. However, when the woman cannot cope with labor pain, it is easier for the woman to cope with labor pain with holistic birth support strategies such as providing physical comfort, emotional comfort, informative support and advocacy.
- Conditions
- Labor Pain
- Being tested
- holistic birth support strategies
- Keywords
- coping with labor pain, birth satisfaction, fear of birth
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
holistic birth support strategiesOther
Holistic Birth Support Strategies are composed of birth-supporting practices that were created by Horn and D'Angelo (2017) within the scope of the "Algorithm for Coping with Birth Pain" and recommended for coping with labor pain. Holistic Birth Support Strategies; It includes four parameters: physical comfort, emotional comfort, informative support and advocacy.
| Study group | Role | What they receive |
|---|---|---|
| experiment | Experimental | Women in the experimental group will be given care at the first stage of labor (will start in the latent phase) using Integrated Birth Support Strategies created in line with the Algorithm for Coping with Birth Pain.
Among the interventions made into a checklist, the interventions applied to the woman will be marked by the midwives and nurses working in the delivery room. The Scale for Coping with Birth Pain (DABS), which will be applied once in each phase (latent phase, active phase and transition phase), will guide the delivery of care; Care practices will differ depending on the woman's ability to cope with labor pain.At least 3 of each sub-heading of the physical comfort parameter, at least 1 of each sub-heading of the parameter of providing emotional comfort, at least 2 of each sub-heading of informative support and advocacy sub-parameters will be applied to pregnant women by midwives / nurses working in the delivery room. Receives: Other: holistic birth support strategies |
| control | No intervention | Pregnant women assigned to the control group will be followed up with the routine care applied in the delivery room. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth satisfaction as assessed by the Birth Satisfaction Scale
Measurements will be made using the Birth Satisfaction Scale.The total number of points to be obtained from the scale varies between 30 and 150 points, but the scale does not have a cut-off point. As the scores obtained from the scale increase, the level of birth satisfaction increases.
Measured: will be measured in the first 6 hours postpartum
Fear of childbirth as assessed by the Wijma Birth Expectation/Experience Scale-Version B
Measurements will be made using the Wijma Birth Expectancy / Experience Scale Version B. While the minimum score on the scale is 33, the maximum score is 198. The high scores indicate that the fear of childbirth experienced by women is high.
Measured: will be measured in the first 6 hours postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start25 May 2021
- Primary completion25 Jun 2021
- Study completion25 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was planned as a single center stratified block parallel group randomized controlled experimental study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pinar Akbas, Gazi University
- Investigators
- Şengül YAMAN SÖZBİR, PhD, Principal investigator, Gazi Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883047
- Sponsor's protocol ID
- laborpain
- Status last verified
- Jul 2021
- First submitted
- 26 Apr 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Practices Performed in Accordance With the Algorithm of Coping With Birth Pain on Coping With Birth Pain, Birth Satisfaction and Birth Fear: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04883047
- Acronym / sponsor ID
- laborpain
- Conditions
- Labor Pain
- Keywords
- coping with labor pain, birth satisfaction, fear of birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 25 Jun 2021 (actual)
- First posted
- 12 May 2021 (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.
Although labor pain is a physiological and natural process, when the woman cannot cope with labor pain, the health of the mother and fetus is negatively affected. These negative effects mostly focus on the respiratory system, cardiovascular system, neuroendocrine and limbic system. During birth, the mother becomes exhausted due to pain and has to use all her energy to cope with the pain.When the mother can effectively cope with the pain of labor, she starts motherhood with a positive experience, experiences the happiness of actively participating in the birth of the baby, can participate in practices with health professionals, and the problems that can be seen in the newborn are reduced because there is no need for medication. In this respect, it is extremely important for the mother, baby and family to end the birth process in the best possible way. For this reason, nursing care includes emotional, physical, spiritual and psychosocial continuous birth support and coping with the pain of labor. In this direction, the "algorithm for coping with labor pain" developed includes the interventions that should be done to cope with the pain in labor.
Detailed description
Pain is defined as an unpleasant emotional sensation originating from a certain part of the body, often related to tissue damage, and related to the past experiences of the person. Labor pain is an experience that is a part of a natural process, takes place in a limited time, and is perceived and experienced differently by every woman. Physiological changes during labor such as maternal age, parity, weight of mother and baby, position of the fetus, anatomical structure of the pelvis, cervical dilatation and uterine contractions; psychological factors such as perception of threats to the body or soul, culture, ethnicity, anxiety, loneliness, loss of control, fear that a painful or painful event will occur, anxiety that the baby or himself may be harmed, previous pain experiences and healthcare professionals' communication with the pregnant woman Environmental factors such as noise, lighting, and birth pain significantly affect the pregnant woman's coping with labor pain.
Although labor pain is a physiological and natural process, when the woman cannot cope with labor pain, the health of the mother and fetus is adversely affected. These negative effects mostly focus on the respiratory system, cardiovascular system, neuroendocrine and limbic system. During birth, the mother becomes exhausted due to pain and has to use all her energy to cope with the pain. When the mother cannot cope, she becomes tired, and her oxygen requirement, blood pressure and cardiac out-put increase. Fear and anxiety caused by labor pain increase the release of stress hormones such as adrenaline, noradrenaline and corticosteroid. These hormones reduce the blood flow to the uterus and cause distress in the fetus by reducing the amount of oxygen in the placental flow. In addition, due to the increased adrenaline, it causes a decrease in the amount of oxytocin during delivery. This causes prolongation of labor and more bleeding. At the same time, when the woman is able to cope with labor pain, the formation of tetany in the pregnant woman is prevented by preventing hyper ventilation and hypocapnia formation.
When the mother can effectively cope with the pain of labor, she starts motherhood with a positive experience, experiences the happiness of actively participating in the birth of the baby, can participate in practices with health professionals, and the problems that may be seen in the newborn are reduced since there is no need for medication. In this respect, it is extremely important for the mother, baby and family to end the birth process in the best possible way. For this reason, nursing care includes emotional, physical, spiritual and psychosocial continuous birth support and coping with the pain of labor. Providing non-pharmacological pain relief methods such as relaxation and breathing exercises, massage, positioning, therapeutic communication, listening to music, hot-cold application, partner and family support, providing home environment is associated with a positive birth experience. Accordingly, the "algorithm for coping with labor pain" developed by Roberts et al. (2010) includes the interventions that should be done to cope with the pain at birth. The algorithm for coping with labor pain has two branches. One is the arm that shows pregnant ways of coping with pain, such as rhythmic activity, deep breathing, inner focus, relaxation between contractions, which gives clues to healthcare professionals; Another is the arm that enables the evaluation of the findings that show that the woman cannot cope with labor pain such as clenching her teeth, crying, and inability to focus. According to the algorithm, when a woman can cope with labor pain, there is no need to do any intervention. However, when the woman cannot cope with labor pain, it is easier for the woman to cope with labor pain with holistic birth support strategies such as providing physical comfort, emotional comfort, informative support and advocacy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study was planned as a single center stratified block parallel group randomized controlled experimental study.
| Arm | Type | Receives |
|---|---|---|
| experiment | Experimental | Other: holistic birth support strategiesWomen in the experimental group will be given care at the first stage of labor (will start in the latent phase) using Integrated Birth Support Strategies created in line with the Algorithm for Coping with Birth Pain. Among the interventions made into a checklist, the interventions applied to the woman will be marked by the midwives and nurses working in the delivery room. The Scale for Coping with Birth Pain (DABS), which will be applied once in each phase (latent phase, active phase and transition phase), will guide the delivery of care; Care practices will differ depending on the woman's ability to cope with labor pain.At least 3 of each sub-heading of the physical comfort parameter, at least 1 of each sub-heading of the parameter of providing emotional comfort, at least 2 of each sub-heading of informative support and advocacy sub-parameters will be applied to pregnant women by midwives / nurses working in the delivery room. |
| control | No intervention | –Pregnant women assigned to the control group will be followed up with the routine care applied in the delivery room. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being in the latent phase of labor
- Not being a risky pregnant (gestational diabetes, hypertension, preeclampsia etc.)
- Not having any communication problems (mental, auditory, visual, etc.)
Key exclusion criteria (4 listed)
- Pregnancy does not do the post-test applications
- Not wanting to participate in interventions applied in line with the algorithm for coping with labor pain
- Willing to leave the research
- Delivery by cesarean section
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 |
|---|---|---|
| holistic birth support strategiesHolistic Birth Support Strategies are composed of birth-supporting practices that were created by Horn and D'Angelo (2017) within the scope of the "Algorithm for Coping with Birth Pain" and recommended for coping with labor pain. Holistic Birth Support Strategies; It includes four parameters: physical comfort, emotional comfort, informative support and advocacy. | Other | experiment |
Primary outcome
Birth satisfaction as assessed by the Birth Satisfaction Scale
Time frame: will be measured in the first 6 hours postpartum
Measurements will be made using the Birth Satisfaction Scale.The total number of points to be obtained from the scale varies between 30 and 150 points, but the scale does not have a cut-off point. As the scores obtained from the scale increase, the level of birth satisfaction increases.
Fear of childbirth as assessed by the Wijma Birth Expectation/Experience Scale-Version B
Time frame: will be measured in the first 6 hours postpartum
Measurements will be made using the Wijma Birth Expectancy / Experience Scale Version B. While the minimum score on the scale is 33, the maximum score is 198. The high scores indicate that the fear of childbirth experienced by women is high.
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 8 Jul 2021.
- Individual participant dataSharing planned: Yes
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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.
Şengül YAMAN SÖZBİR, PhD principal investigator
Gazi Universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing holistic birth support strategies in people with Labor Pain, run by Gazi University at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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 8 Jul 2021. 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 Turkey (Türkiye). 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?
Birth satisfaction as assessed by the Birth Satisfaction Scale (time frame: will be measured in the first 6 hours postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2021.