Labor PainNCT06194890
The Effect of Diverting Attention Technique on Labor Pain and Satisfaction
A study testing Distraction technique with comedy video in people with Labor Pain, run by Hitit University at 1 site in Turkey (Türkiye).
Trial summary
Having a patient with pain watch a video can be used to "direct attention to a different direction", which is a part of nursing care in pain management (İnal and Canbulat, 2015). There are studies using different non-invasive methods to reduce pain during labor (Ebrahimian and Bilandi, 2021; Kazeminia et al., 2020). 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?
- Distraction technique with comedy video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Dec 2023to 8 Apr 2024
- 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 active phase of labor,
- Being between the ages of 18-45,
- Knowing Turkish,
- Not having a high-risk pregnancy diagnosis,
- Being over 37 weeks gestational age,
- Volunteering to participate in research.
Who cannot join
- Not knowing Turkish,
- Being diagnosed with a high-risk pregnancy,
- The gestational age is less than 37 weeks,
- Having passed the active phase of labor or being in the latent phase.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Fatma Yıldırım
Çorum, 19600
Fatma Yıldırım, +905466742445, crazy_fotti@hotmail.com
About this study
Official title: The Effect of Diverting Attention Technique on Labor Pain and Satisfaction: Randomized-controlled Study
Having a patient with pain watch a video can be used to "direct attention to a different direction", which is a part of nursing care in pain management (İnal and Canbulat, 2015). There are studies using different non-invasive methods to reduce pain during labor (Ebrahimian and Bilandi, 2021; Kazeminia et al., 2020). However, no randomized controlled study has been found in which comedy videos were watched for labor pain management and birth satisfaction. For this reason, it is planned to investigate the effect of comedy video on pain and birth satisfaction in this study.
Read the detailed description
Pregnancy and birth represent a major crisis and stressful period in a woman's life. The quality of experiences during birth affects the mother's physical and emotional health, her desire to have another child, and her emotional relationship with the child (Vaziri et al., 2012). It is stated that there are relationships between increased maternal birth satisfaction and the quality of care and birth services provided (Jha et al., 2017). Lack of satisfaction can lead to postpartum depression, breastfeeding disorders, changes in the mother's attitude towards having another child in the future, and subsequent changes at birth with associated disorders (Sayed et al., 2018). The applicability of methods that can alleviate pain during the birth stages can turn birth into a positive and satisfying experience (Kordi et al., 2018). Among these methods, non-drug and supportive treatments can improve the mental and emotional aspects of birth by reducing the severity of pain and fear, reduce the frequency of elective caesarean sections, and increase the statistics of natural birth. Despite treatment measures, when a pregnant woman experiences pain and stress, the sympathetic nervous system is constantly stimulated, resulting in an increase in the secretion of catecholamines and therefore an increase in pulse rate and systolic blood pressure (Makvandi et al., 2013). The increase in catecholamines may reduce blood flow from the mother to the fetus, ultimately causing uterine contractions to be less effective and prolonging labor. Therefore, improving maternal and fetal outcomes is recommended to positively impact maternal satisfaction with birth (Zare et al., 2017).
Measures aimed at reducing pain and shortening the length of labor stages may increase maternal satisfaction with the birth experience ( Kordi et al., 2018 ). Maternal and fetal complications limit the use of pharmacological methods to facilitate birth; For this reason, more user-friendly, non-prescription, lower-cost and less complicated methods are preferred (Mirghafourvand et al., 2014). Although there are many techniques available today to make the birth experience enjoyable, it is still important to find more easily applicable methods (Siddiquee et al., 2016). One of the non-medical interventions to reduce sensitivity is the cognitive-behavioral approach; With this approach, the individual's attention is shifted from a painful stimulus to an external stimulus (Indovina et al., 2016). This non-pharmacological approach can be adopted to alleviate stress and lower cortisol concentrations in response to stress. Having a patient with pain watch a video can be used to "direct attention to a different direction", which is a part of nursing care in pain management (İnal and Canbulat, 2015). There are studies using different non-invasive methods to reduce pain during labor (Ebrahimian and Bilandi, 2021; Kazeminia et al., 2020). However, no randomized controlled study has been found in which comedy videos were watched for labor pain management and birth satisfaction. For this reason, it is planned to investigate the effect of comedy video on pain and birth satisfaction in this study.
- Conditions
- Labor Pain
- Being tested
- Distraction technique with comedy video
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distraction technique with comedy videoOther
Women in the intervention group will watch an average of 6 minutes of comedy videos during the active phase, transition phase and latent phase of labor.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | When the patients are admitted, their written consent will be obtained and personal information forms and the Visual Comparison Scale (VAS) pain scale will be applied to all participants. VAS pain scale will be applied to both groups during the active phase of labor with 6-8 cm dilatation and 8-10 cm dilatation phases. At the end of the labor, the "Birth Satisfaction Scale Short Form" will be applied to both groups. |
| Intervention group | Experimental | When the patients are admitted, their written consent will be obtained and personal information forms and the Visual Comparison Scale (VAS) pain scale will be applied to all participants.
Women in the experimental group will watch a 15-20 minute video with comedy content during the active phase of the action (4-6 cm dilation), and no intervention will be made to women in the control group.
VAS pain scale will be applied to both groups during the active phase of labor with 6-8 cm dilatation and 8-10 cm dilatation phases. At the end of the labor, the "Birth Satisfaction Scale Short Form" will be applied to both groups. Receives: Other: Distraction technique with comedy video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Visual Analog Scale for labor pain
Measured: in the labor's 4-6, 6-8,8-10 cm cervical opening
Secondary outcomes (1)
Birth satisfaction scale
Birth satisfaction scale
Measured: In the 4th stage of labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start8 Dec 2023
- Primary completion8 Feb 2024 (estimated)
- Study completion8 Apr 2024 (estimated)
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.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Yildirim, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194890
- Sponsor's protocol ID
- Hitit_Labor
- Status last verified
- Dec 2023
- First submitted
- 22 Dec 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Diverting Attention Technique on Labor Pain and Satisfaction: Randomized-controlled Study
- ClinicalTrials.gov ID
- NCT06194890
- Acronym / sponsor ID
- Hitit_Labor
- Conditions
- Labor Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- 8 Feb 2024 (estimated)
- Study completion
- 8 Apr 2024 (estimated)
- First posted
- 8 Jan 2024 (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.
Having a patient with pain watch a video can be used to "direct attention to a different direction", which is a part of nursing care in pain management (İnal and Canbulat, 2015). There are studies using different non-invasive methods to reduce pain during labor (Ebrahimian and Bilandi, 2021; Kazeminia et al., 2020). However, no randomized controlled study has been found in which comedy videos were watched for labor pain management and birth satisfaction. For this reason, it is planned to investigate the effect of comedy video on pain and birth satisfaction in this study.
Detailed description
Pregnancy and birth represent a major crisis and stressful period in a woman's life. The quality of experiences during birth affects the mother's physical and emotional health, her desire to have another child, and her emotional relationship with the child (Vaziri et al., 2012). It is stated that there are relationships between increased maternal birth satisfaction and the quality of care and birth services provided (Jha et al., 2017). Lack of satisfaction can lead to postpartum depression, breastfeeding disorders, changes in the mother's attitude towards having another child in the future, and subsequent changes at birth with associated disorders (Sayed et al., 2018). The applicability of methods that can alleviate pain during the birth stages can turn birth into a positive and satisfying experience (Kordi et al., 2018). Among these methods, non-drug and supportive treatments can improve the mental and emotional aspects of birth by reducing the severity of pain and fear, reduce the frequency of elective caesarean sections, and increase the statistics of natural birth. Despite treatment measures, when a pregnant woman experiences pain and stress, the sympathetic nervous system is constantly stimulated, resulting in an increase in the secretion of catecholamines and therefore an increase in pulse rate and systolic blood pressure (Makvandi et al., 2013). The increase in catecholamines may reduce blood flow from the mother to the fetus, ultimately causing uterine contractions to be less effective and prolonging labor. Therefore, improving maternal and fetal outcomes is recommended to positively impact maternal satisfaction with birth (Zare et al., 2017).
Measures aimed at reducing pain and shortening the length of labor stages may increase maternal satisfaction with the birth experience ( Kordi et al., 2018 ). Maternal and fetal complications limit the use of pharmacological methods to facilitate birth; For this reason, more user-friendly, non-prescription, lower-cost and less complicated methods are preferred (Mirghafourvand et al., 2014). Although there are many techniques available today to make the birth experience enjoyable, it is still important to find more easily applicable methods (Siddiquee et al., 2016). One of the non-medical interventions to reduce sensitivity is the cognitive-behavioral approach; With this approach, the individual's attention is shifted from a painful stimulus to an external stimulus (Indovina et al., 2016). This non-pharmacological approach can be adopted to alleviate stress and lower cortisol concentrations in response to stress. Having a patient with pain watch a video can be used to "direct attention to a different direction", which is a part of nursing care in pain management (İnal and Canbulat, 2015). There are studies using different non-invasive methods to reduce pain during labor (Ebrahimian and Bilandi, 2021; Kazeminia et al., 2020). However, no randomized controlled study has been found in which comedy videos were watched for labor pain management and birth satisfaction. For this reason, it is planned to investigate the effect of comedy video on pain and birth satisfaction in this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –When the patients are admitted, their written consent will be obtained and personal information forms and the Visual Comparison Scale (VAS) pain scale will be applied to all participants. VAS pain scale will be applied to both groups during the active phase of labor with 6-8 cm dilatation and 8-10 cm dilatation phases. At the end of the labor, the "Birth Satisfaction Scale Short Form" will be applied to both groups. |
| Intervention group | Experimental | Other: Distraction technique with comedy videoWhen the patients are admitted, their written consent will be obtained and personal information forms and the Visual Comparison Scale (VAS) pain scale will be applied to all participants. Women in the experimental group will watch a 15-20 minute video with comedy content during the active phase of the action (4-6 cm dilation), and no intervention will be made to women in the control group. VAS pain scale will be applied to both groups during the active phase of labor with 6-8 cm dilatation and 8-10 cm dilatation phases. At the end of the labor, the "Birth Satisfaction Scale Short Form" will be applied to both groups. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Being in the active phase of labor,
- Being between the ages of 18-45,
- Knowing Turkish,
- Not having a high-risk pregnancy diagnosis,
- Being over 37 weeks gestational age,
Key exclusion criteria (4 listed)
- Not knowing Turkish,
- Being diagnosed with a high-risk pregnancy,
- The gestational age is less than 37 weeks,
- Having passed the active phase of labor or being in the latent phase.
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 |
|---|---|---|
| Distraction technique with comedy videoWomen in the intervention group will watch an average of 6 minutes of comedy videos during the active phase, transition phase and latent phase of labor. | Other | Intervention group |
Primary outcome
Visual Analog Scale
Time frame: in the labor's 4-6, 6-8,8-10 cm cervical opening
Visual Analog Scale for labor pain
1 secondary outcome
Birth satisfaction scale
Time frame: In the 4th stage of labor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distraction technique with comedy video in people with Labor Pain, run by Hitit 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 6 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: status not confirmed, as of the sponsor's last update on 8 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: in the labor's 4-6, 6-8,8-10 cm cervical opening). 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 Jan 2024.