Perioperative PsychologyPIMACNCT01141010
Effect of Psychological Interventions on Maternal Outcomes Undergoing Cesarean
A study testing Language in people with Perioperative Psychology, run by Nanjing Medical University at 1 site in China.
Trial summary
Pregnancy induced psychosis is an essential factor that influencing maternal health postpartum. When gravidas, especially nulliparas, facing labor and delivery, they will undoubtedly encounter burden from their own and surrounding facts. Maternal psychosis takes a large part of women's psychological disorders. Read more about this study
- Who is it for?
- Ages 19 to 50 years, women only
- Conditions the study is for
- Perioperative Psychology
- What is being tested?
- Language
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 365 participants
- Where
- 1 siteChina
- Study dates
- May 2010to Aug 2010
- 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 19 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Chinese gravidas
- Gestational age >=36 wk
- Nulliparas
- Undergoing selective Cesarean section
Who cannot join
- With recognition problem
- Used or using centrally acting drugs
- With chronic pain
- Refusal participation
- With existed psychiatric disorders
- With history of psychological diseases
- Contraindications for neuraxial anesthesia
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, 210004
About this study
Official title: Effect of Perioperative Psychological Interventions on Maternal Outcomes Undergoing Cesarean Delivery
Pregnancy induced psychosis is an essential factor that influencing maternal health postpartum. When gravidas, especially nulliparas, facing labor and delivery, they will undoubtedly encounter burden from their own and surrounding facts. Maternal psychosis takes a large part of women's psychological disorders. No matter which way, either spontaneous or surgical, they would choose, many factors influence their psychological state. Cesarean section poses higher risks for women than vaginal delivery. Therefore, how to seek effective methods to alleviate parturients' psychological stress response possesses pivotal clinical implications. Herein the investigators proposed that different linguistic interventions given pre-, intra- or post-operatively would produce different effect on maternal psychology and internal stress level.
- Conditions
- Perioperative Psychology
- Being tested
- Language
- Keywords
- Linguistic, Stress response, Corticosteroid, Cesarean section, Anxiety, Depression, Maternal psychosis
- Medical subject headings
- Fractures, Stress, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LanguageOther
Plain language without psychological intervention
LanguageOther
Also called Psycholinguistic
Psychological linguistic intervention will be given
| Study group | Role | What they receive |
|---|---|---|
| Plain language | Sham comparator | Conventional plain language will be given without any psychological intervention Receives: Other: Language |
| Pre-psycho-language | Active comparator | Prior surgery psychological linguistic intervention Receives: Other: Language |
| Intra-psycho-language | Active comparator | Intraoperative psychological linguistic intervention Receives: Other: Language |
| Post-psycho-language | Active comparator | Postoperative psychological linguistic intervention Receives: Other: Language |
| Combined language | Active comparator | Psychological linguistic intervention will be given in a combination of pre-, intra- and post-operatively Receives: Other: Language |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self anxiety assessment scale (SAS)
Scorings of SAS evaluation by the patient herself
Measured: One day prior surgery
Secondary outcomes (16)
Self depression assessment scale (SDS)
Scorings of SDS by the patient herself
Measured: One day prior surgery
Visual analog scale of pain (VAS pain)
Patient self assessed pain scorings with a 100 mm (0-100) scale
Measured: Five min before surgery (-5 min)
Saliva cortisol level
Saliva cortisol levels will be measured with EIA
Measured: One day prior surgery
Vital signs
Blood pressure, heart rate, respiratory rate, oral temperature
Measured: One day prior surgery
SAS scorings
Scorings of SAS by patient herself
Measured: 15 min intraoperation
SAS scorings
Scorings of SAS by the patient herself
Measured: 30 min postoperation
SDS scoring
Scorings of SDS by patient herself
Measured: 15 min intraoperation
SDS scoring
Scorings of SDS by patient herself
Measured: 30 min postoperation
VAS pain scoring
VAS scorings of pain by a 100 mm scale
Measured: Immediately of surgery (0 min)
VAS pain scoring
Scorings of VAS pain by a 100 mm scale
Measured: 5 min after surgery begin (+5 min)
VAS pain scoring
Scorings of VAS pain by a 100 mm scale
Measured: Immediately at the end of surgery (this time changed individually)
VAS pain scoring
Scorings of VAS pain by a 100 mm scale
Measured: 3 h after surgery
Saliva cortisol level
Saliva cortisol level will be measured with EIA
Measured: 15 min intraoperation
Saliva cortisol level
Saliva cortisol level will be measured with EIA
Measured: 30 min postoperation
Vital signs
Blood pressure, heart rate, respiratory rate, oral temperature
Measured: 15 min intraoperation
Vital signs
Blood pressure, heart rate, respiratory rate, oral temperature
Measured: 30 min postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative PsychologyStudies of the same condition, open and under way.
- More trials run by Nanjing Medical 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Confidential Enquiry into Maternal and Child Health
- Investigators
- DongYing Fu, MSc, Study director, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141010
- Sponsor's protocol ID
- NJFY1021005
- Other IDs
- 10NJMS067
- Acronym
- PIMAC
- Status last verified
- Aug 2010
- First submitted
- 3 Jun 2010
- Last updated
- 25 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Psychological Interventions on Maternal Outcomes Undergoing Cesarean Delivery
- ClinicalTrials.gov ID
- NCT01141010
- Acronym / sponsor ID
- PIMAC / NJFY1021005
- Conditions
- Perioperative Psychology
- Keywords
- Linguistic, Stress response, Corticosteroid, Cesarean section, Anxiety, Depression, Maternal psychosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Confidential Enquiry into Maternal and Child Health
- Study start
- May 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 10 Jun 2010 (estimated)
- 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.
Pregnancy induced psychosis is an essential factor that influencing maternal health postpartum. When gravidas, especially nulliparas, facing labor and delivery, they will undoubtedly encounter burden from their own and surrounding facts. Maternal psychosis takes a large part of women's psychological disorders. No matter which way, either spontaneous or surgical, they would choose, many factors influence their psychological state. Cesarean section poses higher risks for women than vaginal delivery. Therefore, how to seek effective methods to alleviate parturients' psychological stress response possesses pivotal clinical implications. Herein the investigators proposed that different linguistic interventions given pre-, intra- or post-operatively would produce different effect on maternal psychology and internal stress level.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Plain language | Sham comparator | Other: LanguageConventional plain language will be given without any psychological intervention |
| Pre-psycho-language | Active comparator | Other: LanguagePrior surgery psychological linguistic intervention |
| Intra-psycho-language | Active comparator | Other: LanguageIntraoperative psychological linguistic intervention |
| Post-psycho-language | Active comparator | Other: LanguagePostoperative psychological linguistic intervention |
| Combined language | Active comparator | Other: LanguagePsychological linguistic intervention will be given in a combination of pre-, intra- and post-operatively |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Chinese gravidas
- Gestational age >=36 wk
- Nulliparas
- Undergoing selective Cesarean section
Key exclusion criteria (7 listed)
- With recognition problem
- Used or using centrally acting drugs
- With chronic pain
- Refusal participation
- With existed 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 |
|---|---|---|
| LanguagePlain language without psychological intervention | Other | Plain language |
| LanguageAlso: PsycholinguisticPsychological linguistic intervention will be given | Other | Combined language, Intra-psycho-language, Post-psycho-language, Pre-psycho-language |
Primary outcome
Self anxiety assessment scale (SAS)
Time frame: One day prior surgery
Scorings of SAS evaluation by the patient herself
16 secondary outcomes
Self depression assessment scale (SDS)
Time frame: One day prior surgery
Visual analog scale of pain (VAS pain)
Time frame: Five min before surgery (-5 min)
Saliva cortisol level
Time frame: One day prior surgery
Vital signs
Time frame: One day prior surgery
SAS scorings
Time frame: 15 min intraoperation
SAS scorings
Time frame: 30 min postoperation
SDS scoring
Time frame: 15 min intraoperation
SDS scoring
Time frame: 30 min postoperation
VAS pain scoring
Time frame: Immediately of surgery (0 min)
VAS pain scoring
Time frame: 5 min after surgery begin (+5 min)
VAS pain scoring
Time frame: Immediately at the end of surgery (this time changed individually)
VAS pain scoring
Time frame: 3 h after surgery
Saliva cortisol level
Time frame: 15 min intraoperation
Saliva cortisol level
Time frame: 30 min postoperation
Vital signs
Time frame: 15 min intraoperation
Vital signs
Time frame: 30 min postoperation
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 25 Aug 2010.
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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.
DongYing Fu, MSc study director
Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Language in people with Perioperative Psychology, run by Nanjing Medical University at 1 site in China.
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 4 inclusion and 7 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 25 Aug 2010. 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 China. 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?
Self anxiety assessment scale (SAS) (time frame: One day prior surgery). 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 25 Aug 2010.