<codeBook xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:xsd="http://www.w3.org/2001/XMLSchema" xsi:schemaLocation="ddi:codebook:2_5 http://www.ddialliance.org/Specification/DDI-Codebook/2.5/XMLSchema/codebook.xsd" xmlns="ddi:codebook:2_5">
  <docDscr>
    <citation>
      <titlStmt>
        <titl xml:lang="sv">Tillägg av melatonin för behandling av endometrios-associerad bäckensmärta - en randomiserad dubbelblindad, placebokontrollerad studie</titl>
        <parTitl xml:lang="en">Adjuvant use of melatonin for pain management in endometriosis-associated pelvic pain - a randomized double-blinded, placebo-controlled trial</parTitl>
        <IDNo agency="SND">2023-28-1-1</IDNo>
        <IDNo agency="DOI">https://doi.org/10.48723/875f-ma81</IDNo>
      </titlStmt>
      <prodStmt>
        <producer xml:lang="en" abbr="SND">Swedish National Data Service</producer>
        <producer xml:lang="sv" abbr="SND">Svensk nationell datatjänst</producer>
      </prodStmt>
      <holdings URI="https://doi.org/10.48723/875f-ma81">Landing page</holdings>
    </citation>
  </docDscr>
  <stdyDscr>
    <citation>
      <titlStmt>
        <titl xml:lang="sv">Tillägg av melatonin för behandling av endometrios-associerad bäckensmärta - en randomiserad dubbelblindad, placebokontrollerad studie</titl>
        <parTitl xml:lang="en">Adjuvant use of melatonin for pain management in endometriosis-associated pelvic pain - a randomized double-blinded, placebo-controlled trial</parTitl>
        <IDNo agency="SND">2023-28-1-1</IDNo>
        <IDNo agency="DOI">https://doi.org/10.48723/875f-ma81</IDNo>
        <IDNo agency="SwePub">oai:DiVA.org:liu-196852</IDNo>
        <IDNo agency="DOI">10.1371/journal.pone.0286182</IDNo>
      </titlStmt>
      <rspStmt>
        <AuthEnty xml:lang="en" affiliation="Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet">Marions, Lena</AuthEnty>
        <AuthEnty xml:lang="sv" affiliation="Institutionen för klinisk forskning och utbildning, Södersjukhuset, Karolinska Institutet">Marions, Lena</AuthEnty>
      </rspStmt>
      <prodStmt />
      <distStmt>
        <distrbtr xml:lang="en" abbr="SND" URI="https://snd.se">Swedish National Data Service</distrbtr>
        <distrbtr xml:lang="sv" abbr="SND" URI="https://snd.se">Svensk nationell datatjänst</distrbtr>
        <distDate xml:lang="en" date="2023-03-24" />
      </distStmt>
      <verStmt>
        <version elementVersion="1" elementVersionDate="2023-03-24" />
      </verStmt>
      <holdings URI="https://doi.org/10.48723/875f-ma81">Landing page</holdings>
    </citation>
    <stdyInfo>
      <subject>
        <keyword xml:lang="en" vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D004715">Endometriosis</keyword>
        <keyword xml:lang="sv" vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D004715">Endometrios</keyword>
        <keyword xml:lang="en" vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008550">Melatonin</keyword>
        <keyword xml:lang="sv" vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008550">Melatonin</keyword>
      </subject>
      <abstract xml:lang="en" contentType="abstract">Purpose: Considering the pharmacological treatment options for endometriosis-associated pain are confined to hormonal therapy and analgesics, we studied the analgesic effect of 20 mg melatonin as an adjuvant therapy in women with endometriosis-associated pain.
Methods: This randomized double-blinded, placebo-controlled trial was conducted at the Research Center for Womens’ Health at Södersjukhuset, a university hospital in Stockholm, Sweden. Forty women from 18 to 50 years of age with endometriosis and severe dysmenorrhea with or without chronic pelvic pain were given 20 mg Melatonin or placebo orally daily for two consecutive menstrual cycles or months. The level of pain was recorded daily via questionnaire on the 11-point numeric rating scale. A difference of 1.3 units was considered clinically significant.
Clincaltrials.gov nr NCT03782740.
Results: Sixteen participants completed the study in the placebo group and 18 in the melatonin group. The difference in endometriosis-associated pain between the groups showed to be non-significant statistically as well as clinically. 
Conclusion: This randomized, double-blinded, placebo-controlled trial could not show that 20 mg of melatonin given orally at bedtime had better analgesic effect on endometriosis-associated pain as compared with placebo. However, no adverse effects were observed.

The dataset consists of a csv fil (RCT_mel_endo.csv) with responses from the survey.</abstract>
      <abstract xml:lang="sv" contentType="abstract">Efter en månads screening randomiserades och lottades fyrtio personer med endometrios till 20 mg melatonin eller placebo för två månaders daglig behandling. Den endometriosrelaterade smärtan utvärderades dagligen via frågeformulär liksom intag av analgetika och andra smärtor såsom dypareuni, dysuri, dyschezi. EHP-30 och katastrofiering (PCS) utvärderades också.
Ingen skillnad mellan grupperna sågs. För mer info vg se nedan.

Dataset består av en csv fil (RCT_mel_endo.csv) med enkätsvar.</abstract>
      <sumDscr>
        <collDate xml:lang="en" date="2019-08-21" event="start">2019-08-21</collDate>
        <collDate xml:lang="en" date="2021-06-27" event="end">2021-06-27</collDate>
        <nation xml:lang="en" abbr="SE">Sweden</nation>
        <nation xml:lang="sv" abbr="SE">Sverige</nation>
        <universe xml:lang="en">Fyrtio kvinnor, 18-50 år med endometrios och svår mensvärk</universe>
        <universe xml:lang="sv">Forty women from 18 to 50 years of age with endometriosis and severe dysmenorrhea</universe>
        <dataKind xml:lang="en">Numeric</dataKind>
      </sumDscr>
    </stdyInfo>
    <method>
      <dataColl>
        <collMode xml:lang="en">Self-administered questionnaire<concept vocab="DDI Mode of Collection" vocabURI="https://vocabularies.cessda.eu/v2/vocabularies/ModeOfCollection/5.0.0?languageVersion=en-5.0.0">Self-administered questionnaire</concept></collMode>
        <collMode xml:lang="sv">Självadministrerat frågeformulär<concept vocab="DDI Mode of Collection" vocabURI="https://vocabularies.cessda.eu/v2/vocabularies/ModeOfCollection/5.0.0?languageVersion=sv-5.0.0">Självadministrerat frågeformulär</concept></collMode>
      </dataColl>
    </method>
    <dataAccs>
      <useStmt>
        <restrctn xml:lang="en">Access to data through SND. Access to data is restricted.</restrctn>
        <restrctn xml:lang="sv">Åtkomst till data via SND. Tillgång till data är begränsad.</restrctn>
        <conditions elementVersion="info:eu-repo-Access-Terms vocabulary">restrictedAccess</conditions>
      </useStmt>
    </dataAccs>
    <othrStdyMat>
      <relPubl>
        <citation>
          <titlStmt>
            <titl xml:lang="sv">Soderman, L., Böttiger, Y., Edlund, M., Jaernbert-Pettersson, H., &amp; Marions, L. (2023). Adjuvant use of melatonin for pain management in endometriosis-associated pelvic pain-A randomized double-blinded, placebo-controlled trial. In PLOS ONE (Vol. 18, Issue 6). https://doi.org/10.1371/journal.pone.0286182</titl>
            <parTitl xml:lang="en">Soderman, L., Böttiger, Y., Edlund, M., Jaernbert-Pettersson, H., &amp; Marions, L. (2023). Adjuvant use of melatonin for pain management in endometriosis-associated pelvic pain-A randomized double-blinded, placebo-controlled trial. In PLOS ONE (Vol. 18, Issue 6). https://doi.org/10.1371/journal.pone.0286182</parTitl>
            <IDNo agency="DOI">10.1371/journal.pone.0286182</IDNo>
            <IDNo agency="SWEPUB">oai:DiVA.org:liu-196852</IDNo>
          </titlStmt>
          <distStmt>
            <distDate date="2023">2023</distDate>
          </distStmt>
          <any xml:lang="en" xmlns="http://purl.org/dc/elements/1.1/">oai:DiVA.org:liu-196852</any>
        </citation>
      </relPubl>
    </othrStdyMat>
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