Labor PainNCT05411289
The Effect of Acupressure on Labor Pain and Anxiety Levels During Labor in Primiparas Women
A study testing acupressure in people with Labor Pain, run by Cairo University at 1 site in Egypt.
Trial summary
the effect of acupressure on labor pain and anxiety levels during labor in primiparas women Read more about this study
- Who is it for?
- Ages 20 to 30 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- acupressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jun 2022to 15 Jul 2022
- 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 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Primiparas women aged from 20 to 30 years old,
- gestational age of between 37 and 40 weeks according to ultrasonography.
- A fetal weight of between 2500 and 3500 g according to ultrasonography or clinical examination .
- They are transferred to labor room if active labor is in progress (defined as cervical dilatation 3 cm and the presence of regular uterine contraction,
- having a single and healthy fetus in the vertex position
Who cannot join
- who were needing an emergency C-section.
- Women having a current or previous high-risk pregnancy
- who have experienced pregnancy complications
- Women with a systemic disease during pregnancy . Women with a psychological disorder
Trial locations and contacts
1 site in 1 country.
About this study
the effect of acupressure on labor pain and anxiety levels during labor in primiparas women
- Conditions
- Labor Pain
- Being tested
- acupressure, sham acupressure
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupressureProcedure or surgery
Pressures were applied on three points consecutively, firstly on two points bilaterally Hugo point (LI4) and He-7 (Shenmen), then pressure was applied on sanyinjiao (SP6).
pressure was applied gradually for 30 seconds on the above mentioned points. Then this pressure was slowly intensified to the extent that the patient felt tingling, numbness, heaviness, and strain in the surrounding area.
sham acupressureProcedure or surgery
Pressures were applied on sham points consecutively
| Study group | Role | What they receive |
|---|---|---|
| acupressure | Experimental | Pressures were applied on three points consecutively, firstly on two points bilaterally Hugo point (LI4) and He-7 (Shenmen), then pressure was applied on sanyinjiao (SP6) Receives: Procedure: acupressure |
| sham acupressure | Sham comparator | Not described Receives: Procedure: sham acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety level
To measure anxiety, the Spiberger inventory questionnaire will be used
Measured: about one hour
labor pain
labor pain will be assessed using visual analogue scale.
. It employs a 10-cm ruler scale with no pain sign at one end and the most intense pain sign at the other to allow users to assess their own pain
Measured: about one hour
Secondary outcomes (2)
pulse rate response
will measured using pulse oximetry
Measured: about one hour
blood pressure response
will measured using sphygmomanometer
Measured: about one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start7 Jun 2022
- Primary completion8 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Cairo 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mohamed Taha, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411289
- Sponsor's protocol ID
- P.T.REC/012/003704
- Status last verified
- Nov 2022
- First submitted
- 6 Jun 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hasanin ME, Elsayed SH, Taha MM. Effect of Acupressure on Anxiety and Pain Levels in Primiparous Women During Normal Labor: A Randomized Controlled Trial. J Integr Complement Med. 2024 Jul;30(7):654-661. doi: 10.1089/jicm.2023.0072. Epub 2023 Dec 20.
PubMed 38117578
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupressure on Labor Pain and Anxiety Levels During Labor in Primiparas Women
- ClinicalTrials.gov ID
- NCT05411289
- Acronym / sponsor ID
- P.T.REC/012/003704
- Conditions
- Labor Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 8 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 9 Jun 2022 (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.
the effect of acupressure on labor pain and anxiety levels during labor in primiparas women
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupressure | Experimental | Procedure: acupressurePressures were applied on three points consecutively, firstly on two points bilaterally Hugo point (LI4) and He-7 (Shenmen), then pressure was applied on sanyinjiao (SP6) |
| sham acupressure | Sham comparator | Procedure: sham acupressure |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Primiparas women aged from 20 to 30 years old,
- gestational age of between 37 and 40 weeks according to ultrasonography.
- A fetal weight of between 2500 and 3500 g according to ultrasonography or clinical examination .
- They are transferred to labor room if active labor is in progress (defined as cervical dilatation 3 cm and the presence of regular uterine contraction,
- having a single and healthy fetus in the vertex position
Key exclusion criteria (4 listed)
- who were needing an emergency C-section.
- Women having a current or previous high-risk pregnancy
- who have experienced pregnancy complications
- Women with a systemic disease during pregnancy . Women with a psychological disorder
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 |
|---|---|---|
| acupressurePressures were applied on three points consecutively, firstly on two points bilaterally Hugo point (LI4) and He-7 (Shenmen), then pressure was applied on sanyinjiao (SP6). pressure was applied gradually for 30 seconds on the above mentioned points. Then this pressure was slowly intensified to the extent that the patient felt tingling, numbness, heaviness, and strain in the surrounding area. | Procedure or surgery | acupressure |
| sham acupressurePressures were applied on sham points consecutively | Procedure or surgery | sham acupressure |
Primary outcome
Anxiety level
Time frame: about one hour
To measure anxiety, the Spiberger inventory questionnaire will be used
labor pain
Time frame: about one hour
labor pain will be assessed using visual analogue scale. . It employs a 10-cm ruler scale with no pain sign at one end and the most intense pain sign at the other to allow users to assess their own pain
2 secondary outcomes
pulse rate response
Time frame: about one hour
blood pressure response
Time frame: about one hour
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 29 Nov 2022.
- Derived from this study: PubMed 38117578Hasanin ME, Elsayed SH, Taha MM. Effect of Acupressure on Anxiety and Pain Levels in Primiparous Women During Normal Labor: A Randomized Controlled Trial. J Integr Complement Med. 2024 Jul;30(7):654-661. doi: 10.1089/jicm.2023.0072. Epub 2023 Dec 20.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupressure in people with Labor Pain, run by Cairo University at 1 site in Egypt.
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 5 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 29 Nov 2022. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Anxiety level (time frame: about one hour). 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?
On the ClinicalTrials.gov record for NCT05411289, which also lists 1 linked publication.
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 29 Nov 2022.