Pelvic Organ ProlapsePHSPOPCNCT02502357
Healing Statements and Their Effect on Post Operative Pain
A study testing Healing Statements in people with Pelvic Organ Prolapse, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
This is a randomized clinical trial comparing the severity of post-operative pain and use of pain medication in women who are and are not exposed to healing statements before undergoing vaginal hysterectomy with minimally invasive sacrocolpopexy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Healing Statements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 14 Sep 2016
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who undergo vaginal hysterectomy with minimally invasive sacrocolpopexy
- Age ≥18 years
- English speaking
- Available for 2 week follow up
- Able to complete study questionnaires
Who cannot join
- History of chronic pain prior to surgery
- Pain during intercourse or in lower abdomen or genital region at baseline prior to index surgery (identified if patient answers yes to question 20 on the Pelvic Floor Distress Inventory-20)
- Hearing impairment
- Pregnancy by self-report or positive pregnancy test
- Active pelvic infection, herpes, candidiasis
- Indication for surgery is due to neoplasm
- History of pain syndromes including fibromyalgia, interstitial cystitis, dysmenorrhea, and depression
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: The Power of Healing Statements on Post Operative Pain Control: A Randomized Controlled Trial
This is a randomized clinical trial comparing the severity of post-operative pain and use of pain medication in women who are and are not exposed to healing statements before undergoing vaginal hysterectomy with minimally invasive sacrocolpopexy. The investigators' hypothesis is that those who are read healing statements before surgery will require less post-operative pain medications and experience less severe pain than those who do not hear the statements.
Read the detailed description
This is a randomized controlled trial of women undergoing vaginal hysterectomy with minimally invasive sacrocolpopexy. Eligible patients will be approached for study participation after they have decided to proceed with the vaginal hysterectomy with minimally invasive sacrocolpopexy. After enrollment, demographics including age, race, prolapse stage, and medical history will be collected. Before vaginal hysterectomy with minimally invasive sacrocolpopexy in the OR, they will be randomized to the group that will be read healing statements or to the group without healing statements. Women randomized to the healing statement group will have the following statements read to them by a trained research staff member, using Peggy Huddleston's technique. Before the patient is placed under general anesthesia, the study staff member will repeat 5 times:
"Following this operation, [the participant] will feel very comfortable and [the participant] will heal very well"
Toward the end of the surgery, the study staff member will say 5 times:
"The operation has gone very well." "Following the operation, [the participant] will be hungry. [The participant] will be thirsty and urinate easily."
Prior to reading these statements to the patient, the research staff member will listen to a previously recorded audio sample of how the statements should be read with regard to tone of voice and attitude.
Patients will then fill out the VAS pain scale 6 and 24 hours after surgery. Pain medication use, dosage, type of medication will be assessed by examining electronic medical records. Time to pass void trial and time to first bowel movement will be recorded on paper and brought to the patient's 2-week follow up visit. Nausea will be assessed 6 and 24 hours after surgery using the Postoperative Nausea and Vomiting (PONV) Intensity Scale. Patients will be given standard post-operative instructions for a vaginal hysterectomy with minimally invasive sacrocolpopexy, and be told to come to the clinic in 2 weeks for a follow up visit. During this time, the will be told to keep a daily diary of pain medication use including name, dosage, and amount taken. At the 2-week visit, the patient will fill out another VAS pain scale and PFDI-20 and their pain medication diaries will be collected. The patient's overall sense of recovery will be assessed using the PGI. Once the data is collected, statistical analysis will be performed.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Healing Statements
- Keywords
- pain control, healing statements, pelvic prolapse
- Medical subject headings
- Pelvic Organ Prolapse, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healing StatementsOther
Before the patient in the experimental group is placed under general anesthesia, the study staff member will repeat 5 times:
"Following this operation, [the participant] will feel very comfortable and [the participant] will heal very well."
Toward the end of the surgery, the study staff member will say 5 times:
"The operation has gone very well." "Following the operation, [the participant] will be hungry. [The participant] will be thirsty and urinate easily."
| Study group | Role | What they receive |
|---|---|---|
| Healing Statements | Experimental | Patients in the healing statements group will be read healing statements during anesthesia induction, prior to undergoing surgery. Receives: Other: Healing Statements |
| No Healing Statements | No intervention | Patients in the no healing statements group will not be read healing statements during anesthesia induction prior to undergoing surgery. They will receive standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Pain (analyzed by VAS Numeric Pain Distress Scale)
Pain
Measured: baseline
Post Operative Pain (analyzed by VAS Numeric Pain Distress Scale)
Pain
Measured: 6 hours after surgery
Post Operative Pain (analyzed by VAS Numeric Pain Distress Scale)
Pain
Measured: 24 hours after surgery
Post Operative Pain (analyzed by VAS Numeric Pain Distress Scale)
Pain
Measured: 2 weeks after surgery
Secondary outcomes (4)
Post operative Nausea and Vomiting (analyzed by Post-Operative Nausea and Vomiting Intensity Scale)
Nausea and Vomiting
Measured: 6 hours after surgery and 24 hours after surgery
Time to First Bowel Movement
Bowel Movement
Measured: Followed for 2 weeks after surgery
Time to Pass Void Trial (Urination)
Urination
Measured: Followed for 2 weeks after surgery
Patient Perception of Improvement
Patient Perception of Improvement measured by Patient Global Perception of Improvement Scale
Measured: 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startJul 2015
- Primary completion8 Mar 2016
- Study completion14 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheryl Iglesia, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502357
- Sponsor's protocol ID
- 2015-043
- Acronym
- PHSPOPC
- Status last verified
- Aug 2020
- First submitted
- 16 Jun 2015
- Last updated
- 21 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Evans C, Richardson PH. Improved recovery and reduced postoperative stay after therapeutic suggestions during general anaesthesia. Lancet. 1988 Aug 27;2(8609):491-3. doi: 10.1016/s0140-6736(88)90131-6.
PubMed 2900410Block RI, Ghoneim MM, Sum Ping ST, Ali MA. Efficacy of therapeutic suggestions for improved postoperative recovery presented during general anesthesia. Anesthesiology. 1991 Nov;75(5):746-55. doi: 10.1097/00000542-199111000-00005.
PubMed 1952199Liu WH, Standen PJ, Aitkenhead AR. Therapeutic suggestions during general anaesthesia in patients undergoing hysterectomy. Br J Anaesth. 1992 Mar;68(3):277-81. doi: 10.1093/bja/68.3.277.
PubMed 1547052McLintock TT, Aitken H, Downie CF, Kenny GN. Postoperative analgesic requirements in patients exposed to positive intraoperative suggestions. BMJ. 1990 Oct 6;301(6755):788-90. doi: 10.1136/bmj.301.6755.788.
PubMed 2224266Huddleston P. Prepare for Surgery, Heal Faster: A Guide of Mindy-Body Techniques. Angel River Press, 2012.
Watters M, Feldman J, Schoetz D, Abrams M, Goy C, Catman M, Huddleston P. The Power of Relaxation: A Holistic Approach to Preoperative Patient Education.
Huddleston M, Bierbaum B. Cost-effectiveness of Using Mind-Body Techniques for Total Knee-Joint Replacement.
Hutchings DD. The value of suggestion given under anesthesia: A report and evaluation of 200 cases. American Journal of Clinical Hypnosis 1961; 26-29.
Furlong M. Positive suggestions presented during anaesthesia. Memory and Awareness in Anaesthesia (Amsterdam: Swets & Zeitlinger, 1990).
Lebovits AH, Twersky R, McEwan B. Intraoperative therapeutic suggestions in day-case surgery: are there benefits for postoperative outcome? Br J Anaesth. 1999 Jun;82(6):861-6. doi: 10.1093/bja/82.6.861.
PubMed 10562780Wolfe LS, Millet JB. Control of postoperative pain by suggestion under general anesthesia. American Journal of Clinical Hypnosis 1960; 3:109-112.
Steinberg ME, Hord AH, Reed B, Sebels PS. Study of the effect of intraoperative analgesia and well-being. Memory and Awareness in Anesthesia (Englewood Cliffs, NJ: Prenctice Hall, 1993).
Shah NM, Andriani LA, Mofidi JL, Ingraham CF, Tefera EA, Iglesia CB. Therapeutic Suggestion in Postoperative Pain Control: A Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2021 Jul 1;27(7):409-414. doi: 10.1097/SPV.0000000000000906.
PubMed 32541300
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Power of Healing Statements on Post Operative Pain Control: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02502357
- Acronym / sponsor ID
- PHSPOPC / 2015-043
- Conditions
- Pelvic Organ Prolapse
- Keywords
- pain control, healing statements, pelvic prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- 8 Mar 2016 (actual)
- Study completion
- 14 Sep 2016 (actual)
- First posted
- 20 Jul 2015 (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.
This is a randomized clinical trial comparing the severity of post-operative pain and use of pain medication in women who are and are not exposed to healing statements before undergoing vaginal hysterectomy with minimally invasive sacrocolpopexy. The investigators' hypothesis is that those who are read healing statements before surgery will require less post-operative pain medications and experience less severe pain than those who do not hear the statements.
Detailed description
This is a randomized controlled trial of women undergoing vaginal hysterectomy with minimally invasive sacrocolpopexy. Eligible patients will be approached for study participation after they have decided to proceed with the vaginal hysterectomy with minimally invasive sacrocolpopexy. After enrollment, demographics including age, race, prolapse stage, and medical history will be collected. Before vaginal hysterectomy with minimally invasive sacrocolpopexy in the OR, they will be randomized to the group that will be read healing statements or to the group without healing statements. Women randomized to the healing statement group will have the following statements read to them by a trained research staff member, using Peggy Huddleston's technique. Before the patient is placed under general anesthesia, the study staff member will repeat 5 times:
"Following this operation, [the participant] will feel very comfortable and [the participant] will heal very well"
Toward the end of the surgery, the study staff member will say 5 times:
"The operation has gone very well." "Following the operation, [the participant] will be hungry. [The participant] will be thirsty and urinate easily."
Prior to reading these statements to the patient, the research staff member will listen to a previously recorded audio sample of how the statements should be read with regard to tone of voice and attitude.
Patients will then fill out the VAS pain scale 6 and 24 hours after surgery. Pain medication use, dosage, type of medication will be assessed by examining electronic medical records. Time to pass void trial and time to first bowel movement will be recorded on paper and brought to the patient's 2-week follow up visit. Nausea will be assessed 6 and 24 hours after surgery using the Postoperative Nausea and Vomiting (PONV) Intensity Scale. Patients will be given standard post-operative instructions for a vaginal hysterectomy with minimally invasive sacrocolpopexy, and be told to come to the clinic in 2 weeks for a follow up visit. During this time, the will be told to keep a daily diary of pain medication use including name, dosage, and amount taken. At the 2-week visit, the patient will fill out another VAS pain scale and PFDI-20 and their pain medication diaries will be collected. The patient's overall sense of recovery will be assessed using the PGI. Once the data is collected, statistical analysis will be performed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healing Statements | Experimental | Other: Healing StatementsPatients in the healing statements group will be read healing statements during anesthesia induction, prior to undergoing surgery. |
| No Healing Statements | No intervention | –Patients in the no healing statements group will not be read healing statements during anesthesia induction prior to undergoing surgery. They will receive standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women who undergo vaginal hysterectomy with minimally invasive sacrocolpopexy
- Age ≥18 years
- English speaking
- Available for 2 week follow up
- Able to complete study questionnaires
Key exclusion criteria (7 listed)
- History of chronic pain prior to surgery
- Pain during intercourse or in lower abdomen or genital region at baseline prior to index surgery (identified if patient answers yes to question 20 on the Pelvic Floor Distress Inventory-20)
- Hearing impairment
- Pregnancy by self-report or positive pregnancy test
- Active pelvic infection, herpes, candidiasis
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 |
|---|---|---|
| Healing StatementsBefore the patient in the experimental group is placed under general anesthesia, the study staff member will repeat 5 times: "Following this operation, [the participant] will feel very comfortable and [the participant] will heal very well." Toward the end of the surgery, the study staff member will say 5 times: "The operation has gone very well." "Following the operation, [the participant] will be hungry. [The participant] will be thirsty and urinate easily." | Other | Healing Statements |
Primary outcome
Baseline Pain (analyzed by VAS Numeric Pain Distress Scale)
Time frame: baseline
Pain
Post Operative Pain (analyzed by VAS Numeric Pain Distress Scale)
Time frame: 6 hours after surgery
Pain
Post Operative Pain (analyzed by VAS Numeric Pain Distress Scale)
Time frame: 24 hours after surgery
Pain
Post Operative Pain (analyzed by VAS Numeric Pain Distress Scale)
Time frame: 2 weeks after surgery
Pain
4 secondary outcomes
Post operative Nausea and Vomiting (analyzed by Post-Operative Nausea and Vomiting Intensity Scale)
Time frame: 6 hours after surgery and 24 hours after surgery
Time to First Bowel Movement
Time frame: Followed for 2 weeks after surgery
Time to Pass Void Trial (Urination)
Time frame: Followed for 2 weeks after surgery
Patient Perception of Improvement
Time frame: 2 weeks after surgery
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 21 Aug 2020.
- Results publication: PubMed 2900410Evans C, Richardson PH. Improved recovery and reduced postoperative stay after therapeutic suggestions during general anaesthesia. Lancet. 1988 Aug 27;2(8609):491-3. doi: 10.1016/s0140-6736(88)90131-6.
- Results publication: PubMed 1952199Block RI, Ghoneim MM, Sum Ping ST, Ali MA. Efficacy of therapeutic suggestions for improved postoperative recovery presented during general anesthesia. Anesthesiology. 1991 Nov;75(5):746-55. doi: 10.1097/00000542-199111000-00005.
- Results publication: PubMed 1547052Liu WH, Standen PJ, Aitkenhead AR. Therapeutic suggestions during general anaesthesia in patients undergoing hysterectomy. Br J Anaesth. 1992 Mar;68(3):277-81. doi: 10.1093/bja/68.3.277.
- Results publication: PubMed 2224266McLintock TT, Aitken H, Downie CF, Kenny GN. Postoperative analgesic requirements in patients exposed to positive intraoperative suggestions. BMJ. 1990 Oct 6;301(6755):788-90. doi: 10.1136/bmj.301.6755.788.
- Results publicationHuddleston P. Prepare for Surgery, Heal Faster: A Guide of Mindy-Body Techniques. Angel River Press, 2012.
- Results publicationWatters M, Feldman J, Schoetz D, Abrams M, Goy C, Catman M, Huddleston P. The Power of Relaxation: A Holistic Approach to Preoperative Patient Education.
- Results publicationHuddleston M, Bierbaum B. Cost-effectiveness of Using Mind-Body Techniques for Total Knee-Joint Replacement.
- Results publicationHutchings DD. The value of suggestion given under anesthesia: A report and evaluation of 200 cases. American Journal of Clinical Hypnosis 1961; 26-29.
- Results publicationFurlong M. Positive suggestions presented during anaesthesia. Memory and Awareness in Anaesthesia (Amsterdam: Swets & Zeitlinger, 1990).
- Results publication: PubMed 10562780Lebovits AH, Twersky R, McEwan B. Intraoperative therapeutic suggestions in day-case surgery: are there benefits for postoperative outcome? Br J Anaesth. 1999 Jun;82(6):861-6. doi: 10.1093/bja/82.6.861.
- Results publicationWolfe LS, Millet JB. Control of postoperative pain by suggestion under general anesthesia. American Journal of Clinical Hypnosis 1960; 3:109-112.
- Results publicationSteinberg ME, Hord AH, Reed B, Sebels PS. Study of the effect of intraoperative analgesia and well-being. Memory and Awareness in Anesthesia (Englewood Cliffs, NJ: Prenctice Hall, 1993).
Related trials for Pelvic Organ Prolapse
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
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.
Cheryl Iglesia, MD principal investigator
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healing Statements in people with Pelvic Organ Prolapse, run by Medstar Health Research Institute at 1 site in United States.
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 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 21 Aug 2020. 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 United States. 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?
Baseline Pain (analyzed by VAS Numeric Pain Distress Scale) (time frame: baseline). The study lists 4 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 NCT02502357, which also lists 13 linked publications.
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 21 Aug 2020.