Impact of Complementary Medicine Techniques (Therapeutic Touch and Hypno Analgesia) on the Term of Delivery of Patients Hospitalized for Preterm Labor (Hypnorelax) (Hypnorelax)
Primary Purpose
Premature Birth
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Touching relaxant
Hypnoses
Sponsored by
About this trial
This is an interventional prevention trial for Premature Birth focused on measuring threat of premature birth
Eligibility Criteria
Inclusion Criteria:
Pregnant Patient hospitalized for the first time for MAP (preterm labor) at the Robert Debré hospital as defined in CNGOF (National college of French gynecologists and obstetricians):
- frequent and regular uterine contractions (at least 3 in 30 minutes)
- significant cervical changes,
- before 37 weeks of amenorrhea (SA).
- Single or multiple pregnancies
- Age greater than or equal to 18 years
- Patient between 24 + 0 and 32 + 0 weeks of gestation.
- Patient not opposing its participation
- Patient beneficiary of a social security
Exclusion Criteria:
- Not understanding of technology (language barrier ...)
- Psychiatric Pathology (cons-indication to hypnosis: schizophrenia, paranoia)
- Refusal by the patient
- Age <18 years
Sites / Locations
- Perrudin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Touching relaxant
Hypnoses
Standared care
Arm Description
session of massage
session of hypnoses
standard care
Outcomes
Primary Outcome Measures
Number of weeks of gestation
Term of delivery will be assessed
Secondary Outcome Measures
Full Information
NCT ID
NCT02505100
First Posted
July 2, 2015
Last Updated
November 15, 2019
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT02505100
Brief Title
Impact of Complementary Medicine Techniques (Therapeutic Touch and Hypno Analgesia) on the Term of Delivery of Patients Hospitalized for Preterm Labor (Hypnorelax)
Acronym
Hypnorelax
Official Title
Impact of Complementary Medicine Techniques (Therapeutic Touch and Hypno Analgesia) on the Term of Delivery of Patients Hospitalized for Preterm Labor (Hypnorelax)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The threat of premature birth (MAP) is the leading cause of hospitalization during pregnancy complicated by preterm delivery in 5-10% of cases in developed countries. Psychological stress that encompasses anxiety and anxiety resounding including sleep quality can be a work of preacher and premature delivery.
Preterm birth before 37 has an impact on the survival and health of the newborn. It is the leading cause of mortality and obstetric complications. It has a cost both for the newborn, the term parturient health but also the financial cost by the management before delivery and the consequences of a premature birth.
The usual management of MAP is hospitalized with tocolysis, monitoring and rest. The hospitalization and invasive procedures contribute to increasing stress. It therefore seems necessary to seek to diversify and master reputable techniques for their effectiveness on mastering stress and improving sleep quality as hypnosis and feel relaxing.
Hypnosis in obstetrics is used primarily to control pain, nausea and postpartum depression. It also reduces preoperative anxiety and during induction of anesthesia, as well as behavioral disorders during the first postoperative week. Hypnosis can play an important role in the prevention of preterm birth. In a non-randomized study, hypnosis combined with drug therapy has prolonged pregnancy of patients followed in high risk pregnancy.
The relaxing touch brings relaxation and well being. In obstetrics, it has an influence on the anti-stress hormones and plays a role in reducing pain during childbirth.
Few studies interested in hypnosis and relaxation therapies in pregnant women, especially in case of MAP. The published data relate to a small number of patients and a low level of evidence. Although there seems promising results, prospective studies are needed to conclude its effectiveness in improving the stress, pain or other parameters.
Health workers trained in these techniques could observe during their production improved sleep disorders, stress, better communication between doctor and patient. Moreover, these treatments could induce an improvement in the overall care of patients, and therefore have an impact on the continuation of pregnancy.
These findings are based on these hypothesis. There is a clinical gain the contribution of hypnosis and relaxing touch in women hospitalized for MAP before 32 weeks of gestation. This would, among other improvements in sleep disorders and stress, decrease pain, and acting on the extension of the term of pregnancy in women followed by these techniques and a decrease in hospitalizations of newborns premature neonatology and neonatal intensive care units.
Detailed Description
The threat of premature birth (MAP) is the leading cause of hospitalization during pregnancy complicated by preterm delivery in 5-10% of cases in developed countries. Psychological stress that encompasses anxiety and anxiety resounding including sleep quality can be a work of preacher and premature delivery.
Preterm birth before 37 has an impact on the survival and health of the newborn. It is the leading cause of mortality and obstetric complications. It has a cost both for the newborn, the term parturient health but also the financial cost by the management before delivery and the consequences of a premature birth.
The usual management of MAP is hospitalized with tocolysis, monitoring and rest. The hospitalization and invasive procedures contribute to increasing stress. It therefore seems necessary to seek to diversify and master reputable techniques for their effectiveness on mastering stress and improving sleep quality as hypnosis and feel relaxing.
Hypnosis in obstetrics is used primarily to control pain, nausea and postpartum depression. It also reduces preoperative anxiety and during induction of anesthesia, as well as behavioral disorders during the first postoperative week. Hypnosis can play an important role in the prevention of preterm birth. In a non-randomized study, hypnosis combined with drug therapy has prolonged pregnancy of patients followed in high risk pregnancy.
The relaxing touch brings relaxation and well being. In obstetrics, it has an influence on the anti-stress hormones and plays a role in reducing pain during childbirth.
Few studies interested in hypnosis and relaxation therapies in pregnant women, especially in case of MAP. The published data relate to a small number of patients and a low level of evidence. Although there seems promising results, prospective studies are needed to conclude its effectiveness in improving the stress, pain or other parameters.
Health workers trained in these techniques could observe during their production improved sleep disorders, stress, better communication between doctor and patient. Moreover, these treatments could induce an improvement in the overall care of patients, and therefore have an impact on the continuation of pregnancy.
These findings are based on these hypothesis. There is a clinical gain the contribution of hypnosis and relaxing touch in women hospitalized for MAP before 32 weeks of gestation. This would, among other improvements in sleep disorders and stress, decrease pain, and acting on the extension of the term of pregnancy in women followed by these techniques and a decrease in hospitalizations of newborns premature neonatology and neonatal intensive care units.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
threat of premature birth
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Touching relaxant
Arm Type
Experimental
Arm Description
session of massage
Arm Title
Hypnoses
Arm Type
Experimental
Arm Description
session of hypnoses
Arm Title
Standared care
Arm Type
No Intervention
Arm Description
standard care
Intervention Type
Other
Intervention Name(s)
Touching relaxant
Intervention Type
Other
Intervention Name(s)
Hypnoses
Primary Outcome Measure Information:
Title
Number of weeks of gestation
Description
Term of delivery will be assessed
Time Frame
4 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pregnant Patient hospitalized for the first time for MAP (preterm labor) at the Robert Debré hospital as defined in CNGOF (National college of French gynecologists and obstetricians):
frequent and regular uterine contractions (at least 3 in 30 minutes)
significant cervical changes,
before 37 weeks of amenorrhea (SA).
Single or multiple pregnancies
Age greater than or equal to 18 years
Patient between 24 + 0 and 32 + 0 weeks of gestation.
Patient not opposing its participation
Patient beneficiary of a social security
Exclusion Criteria:
Not understanding of technology (language barrier ...)
Psychiatric Pathology (cons-indication to hypnosis: schizophrenia, paranoia)
Refusal by the patient
Age <18 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Céline Perrudin
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Perrudin
City
Paris
ZIP/Postal Code
75019
Country
France
12. IPD Sharing Statement
Learn more about this trial
Impact of Complementary Medicine Techniques (Therapeutic Touch and Hypno Analgesia) on the Term of Delivery of Patients Hospitalized for Preterm Labor (Hypnorelax)
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